Class II FDA device recall · Z-0881-2026

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

Incisive CT; Software Version Number: 4.5, 5.0, 5.1;

Why it was recalled

If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

1) Model Number: 728143; UDI-DI: 00884838085015; Serial Numbers: 500092, 500202, 500309, 500376, 500574, 500265, 500264, 510051, 500034, 500544, 500543, 500548, 500046, 500168, 500064, 500110, 500111, 500102, 500145, 500178, 500255, 500217, 500211, 500216, 500225, 33009, 500242, 500252, 500222, 500282, 33005, 500301, 33001, 33035, 33039, 33002, 33003, 33007, 33013, 33047, 33011, 33008, 33015, 33020, 33010, 33046, 33017, 33019, 33049, 33016, 33024, 33006, 33025, 33034, 33041, 33038, 33031, 33042, 33033, 33037, 33045, 33012, 500032, 500073, 500138, 500308, 33023, 500443, 500410, 500412, 500557, 500038, 500069, 500332, 500397, 510056, 500091, 500135, 510028, 510029, 500591, 500123, 500087, 500136, 500103, 500116, 500105, 500056, 500125, 500041, 500089, 500200, 500152, 500219, 500256, 500213, 500307, 510001, 500233, 500371, 500370, 500377, 510030, 510032, 510031, 500360, 510005, 510020, 500329, 500361, 500436, 500457, 500406, 500465, 500525, 500535, 510027, 500523, 33043, 500028, 500024, 500122, 500173, 510095, 500374, 500003, 500020, 500052, 500075, 500118, 500149, 500150, 500134, 500146, 500218, 500223, 500232, 500299, 500311, 500394, 500435, 500463, 33028, 500480, 500078, 500157, 500153, 500229, 500276, 500310, 500300, 500318, 500336, 500347, 500423, 500372, 500357, 500597, 500351, 500363, 500414, 500390, 500448, 500598, 500399, 500405, 500428, 500391, 500524, 500498, 500422, 500526, 500542, 500541, 500565, 500575, 500578, 500592, 500585, 500593, 500586, 500604, 500581, 500577, 500393, 500210, 500296, 510050, 510026, 500049, 500067, 500076, 500081, 500249, 500368, 500415, 500426, 500522, 500550, 500554, 500569, 500567, 500494, 500187, 500129, 500161, 500175, 500156, 500186, 500141, 500142, 500143, 500144, 500160, 500155, 500185, 500204, 500181, 500182, 500191, 500190, 500201, 500228, 500220, 500221, 500272, 500235, 500237, 500262, 500267, 500268, 500250, 500278, 500275, 500284, 500285, 500287, 500288, 500286, 500293, 510009, 510002, 500334, 510010, 510015, 510016, 500400, 510019, 500438, 510022, 500468, 500442, 510035, 510024, 500458, 510044, 510034, 500528, 500527, 500540, 510037, 510049, 510055, 510060, 510057, 510048, 510066, 510064, 510068, 510065, 510070, 510078, 510071, 510067, 500601, 500576, 500603, 500596, 500617, 510073, 510074, 510075, 510082, 500607, 500606, 500594, 500599, 510076, 510077, 500605, 510081, 510079, 500608, 500609, 500610, 500612, 500611, 510080, 500613, 510083, 510090, 500179, 500195, 500258, 510008, 500384, 510017, 510023, 500483, 500440, 510061, 500446, 500471, 500532, 500556, 500568, 500031, 500159, 500074, 500240, 500615, 500002, 500035, 500040, 500158, 500427, 500043, 500097, 500263, 510059, 500205, 500382, 500184, 500274, 500344, 500392, 500203, 500407, 510069, 500128, 500460, 500238, 500080, 500563, 500126, 500207, 500206, 500338, 510036, 510041, 510038, 510042, 510063, 510062, 510058, 500564, 500572, 500449, 510091, 510088, 510094, 500171, 33032, 33026, 33027, 33044, 33036, 500183, 500188, 500194, 500059, 500403, 500245, 500248, 500051, 500189, 500589, 500172, 500433, 500199, 500402, 500176, 500177, 500552, 500614, 500196, 500424, 500010, 500044, 500227, 500226, 500036, 500047, 500079, 500096, 500409, 500212, 500106, 500241, 500488, 500461, 500472, 500314, 500328, 500339, 500375, 500333, 500487, 500470, 500476, 500071, 500082, 500060, 500099, 500121, 500113, 500120, 500163, 500124, 500215, 500251, 500253, 500254, 500257, 500247, 500273, 500269, 500270, 500271, 500279, 500320, 500356, 500343, 500313, 500321, 500316, 500322, 500324, 500373, 500359, 500330, 500364, 500401, 500459, 500383, 500319, 500350, 510013, 500469, 500416, 500473, 500489, 33029, 500533, 500545, 510052, 500546, 500549, 500553, 500551, 500559, 500618, 33030, 33040, 500083, 500132, 500467, 500478, 500445, 500108, 500112, 500164, 500244, 500331, 500341, 500342, 500386, 500385, 500434, 500451, 500479, 500570, 500571, 500583, 500584, 500590, 500600, 500001, 500004, 500013, 500012, 500014, 500039, 500011, 500054, 500017, 500058, 500045, 500055, 500493, 500197, 500090, 500127, 500131, 500303, 500621, 500346, 500302, 500306, 500353, 500352, 500378, 500354, 500395, 500413, 500623, 500619, 500624, 500622, 500337, 500349, 500450, 500464, 500455, 500490, 500456, 500437, 500482, 500486, 500558, 500562, 500484, 500474, 500485, 500497, 500491, 500495, 500496, 500492, 500616, 500588, 500555, 500561, 500566, 500154, 500139, 500162, 500231, 500539, 500066, 500008, 500026, 500109, 500048, 500137, 500068, 500100, 500367, 500379, 500107, 500305, 500209, 510011, 500174, 500345, 500224, 500214, 510006, 500234, 500239, 510003, 500323, 500326, 500325, 510018, 510033, 500521, 510021, 33022, 500444, 500602, 500317, 500019, 500023, 500018, 500029, 500061, 500104, 500169, 500430, 500208, 500198, 500180, 510004, 510007, 500348, 500595, 500130, 500167, 500114, 500165, 500166, 500312, 510072, 500042, 510025, 500429, 500513, 530001, 530003, 530002, 530004, 530269, 530032, 530008, 530007, 530059, 530005, 530006, 530010, 530009, 530078, 530317, 530062, 530060, 530051, 530044, 530047, 530063, 530054, 530045, 530113, 530015, 530014, 530020, 530026, 530019, 530011, 530013, 530017, 530041, 530018, 530016, 530021, 530056, 530070, 530061, 530057, 530022, 530028, 530024, 530025, 530027, 530023, 530353, 530030, 530038, 530029, 530031, 530012, 530043, 530195, 530033, 530034, 530042, 530037, 530036, 530048, 530053, 530035, 530046, 530171, 530039, 530064, 530040, 530049, 530067, 530071, 530084, 530068, 530052, 530079, 530050, 530082, 530066, 530074, 530058, 530055, 530075, 530069, 530081, 530136, 530073, 530086, 530083, 530065, 530077, 530076, 530072, 530093, 530104, 530094, 530091, 530112, 530085, 530080, 530097, 530087, 530099, 530330, 530176, 530092, 530089, 530174, 530280, 530103, 530316, 530117, 530244, 530102, 530107, 530109, 530300, 530118, 530098, 530241, 530090, 530130, 530088, 530101, 530100, 530131, 530126, 530125, 530114, 530111, 530105, 530106, 530120, 530116, 530096, 530134, 530407, 530121, 530319, 530139, 530127, 530140, 530095, 530115, 530129, 530108, 530142, 530138, 530144, 530141, 530133, 530128, 530302, 530181, 530167, 530182, 530217, 530149, 530246, 530145, 530304, 530219, 530151, 530148, 530283, 530150, 530122, 530173, 530211, 530110, 530216, 530166, 530170, 530153, 530218, 530164, 530221, 530168, 530299, 530322, 530158, 530223, 530157, 530162, 530184, 530206, 530180, 530163, 530143, 530210, 530177, 530188, 530198, 530205, 530240, 530215, 530268, 530214, 530232, 530245, 530230, 530231, 530417, 530321, 530190, 530192, 530194, 530169, 530193, 530213, 530123, 530395, 530156, 530209, 530197, 530196, 530183, 530248, 530247, 530237, 530228, 530313, 530251, 530242, 530265, 530258, 530281, 530593, 530341, 530270, 530286, 530261, 530542, 530267, 530284, 530199, 530276, 530224, 530340, 530239, 530279, 530271, 530235, 530277, 530243, 530262, 530377, 530259, 530278, 530289, 530391, 530288, 530249, 530364, 530285, 530381, 530257, 530260, 530392, 530295, 530305, 530314, 530297, 530333, 530266, 530312, 530290, 530310, 530309, 530327, 530292, 530355, 530324, 530411, 530308, 530323, 530274, 530356, 530371, 530343, 530315, 530325, 530579, 530287, 530574, 530352, 530386, 530383, 530336, 530334, 530382, 530402, 530367, 530375, 530347, 530365, 530444, 530390, 530361, 530418, 530447, 530351, 530346, 530441, 530366, 530410, 530572, 530451, 530478, 530434, 530422, 530423, 530376, 530477, 530429, 530380, 530412, 530359, 530403, 530413, 530414, 530594, 530393, 530405, 530469, 530416, 530471, 530379, 530387, 530385, 530406, 530397, 530440, 530433, 530442, 530424, 530450, 530571, 530394, 530396, 530400, 530399, 530401, 530398, 530426, 530425, 530445, 530454, 530465, 530427, 530497, 530472, 530457, 530428, 530496, 530453, 530467, 530448, 530455, 530438, 530536, 530439, 530446, 530479, 530463, 530459, 530526, 530443, 530513, 530468, 530473, 530484, 530566, 530511, 530512, 530485, 530538, 530487, 530488, 530493, 530491, 530495, 530490, 530499, 530498, 530504, 530503, 530505, 530522, 530583, 530517, 530541, 530544, 530516, 530518, 530556, 530520, 530570, 530519, 530560, 530557, 530525, 530532, 530528, 530558, 530587, 530555, 530531, 530540, 530546, 530539, 530548, 530553, 530551, 530568, 530573, 530586, 530582, 530565, 530580, 530590, 530595, 510014, 500396, 500579, 530354, 500193, 500098, 500327, 500419, 500420, 500388, 500093, 500355, 500380, 510053, 500070, 500065, 500261, 500441, 510012, 500432, 500006, 500447, 500580, 500620, 500304, 500587, 500117, 500404, 500366, 500417, 500007, 500025, 500022, 500033, 500037, 500057, 500027, 500151, 500408, 500050, 500063, 500072, 500094, 500147, 500148, 500398, 500243, 500236, 500246, 500260, 500277, 500335, 510000, 500315, 500369, 500389, 500381, 500466, 500475, 500547, 510054, 500021, 500115, 500053, 500095, 500077, 500170, 500362, 500560, 500230, 500573, 500582;  2) Model Number: 728144; UDI-DI: 00884838105508; Serial numbers: 552070, 552094, 34415, 34010, 552036, 550138, 550133, 552051, 550320, 550076, 550319, 550190, 550230, 550231, 550374, 550126, 34002, 34006, 34007, 34025, 34026, 34018, 34023, 34031, 34033, 34032, 34038, 34041, 34042, 34040, 34051, 34047, 34050, 34049, 34052, 34053, 34054, 34056, 34057, 34055, 34060, 34058, 34059, 34064, 34066, 34072, 34067, 34068, 34071, 34074, 34073, 34078, 34079, 34075, 34077, 34082, 34081, 34083, 34085, 34088, 34090, 34086, 34092, 34091, 34093, 34089, 34112, 34095, 34103, 34097, 34100, 34106, 34102, 34101, 34105, 34111, 34117, 34119, 34116, 34134, 34131, 34133, 34122, 34132, 34137, 34135, 550243, 34126, 34149, 34146, 34128, 34150, 34164, 34162, 34165, 34168, 34169, 34174, 34179, 34187, 34190, 34198, 34195, 34193, 34203, 34191, 34201, 34206, 34208, 34163, 34152, 34160, 34221, 34218, 34226, 34235, 34223, 34240, 34229, 34251, 34153, 34175, 34257, 34259, 34260, 34263, 34265, 34267, 34276, 34277, 34282, 34280, 34279, 34281, 34285, 34294, 34315, 34301, 34324, 34327, 34325, 34289, 34338, 34326, 34337, 34351, 500452, 550016, 550040, 34001, 34151, 34004, 550035, 34166, 552133, 552034, 550165, 550216, 550218, 550242, 34254, 34306, 552086, 500507, 500537, 550027, 550029, 34044, 550090, 550154, 34129, 550295, 34196, 34156, 34209, 550122, 552135, 552134, 550476, 550019, 552002, 500520, 552000, 510040, 510043, 500536, 550000, 550014, 552017, 550088, 550053, 550089, 552005, 552021, 552043, 550132, 550127, 550105, 550160, 550179, 550292, 550262, 550263, 550264, 550271, 550158, 552029, 552056, 552057, 552058, 552067, 552076, 552075, 552074, 550299, 550361, 550343, 550257, 550304, 550244, 550429, 550413, 550193, 550278, 550256, 550261, 550313, 550297, 552114, 552118, 552117, 552115, 552121, 552110, 552090, 552109, 552105, 552081, 550394, 550431, 550446, 550430, 550455, 550497, 550500, 550481, 550444, 550482, 550451, 550443, 550432, 550485, 550463, 552125, 552129, 552128, 552131, 552130, 552126, 552123, 552127, 550504, 550506, 550513, 550507, 550412, 34043, 34065, 34084, 34061, 34180, 34186, 34211, 34212, 34273, 34317, 34349, 552085, 500502, 510039, 550092, 550104, 550162, 550181, 550185, 550200, 550298, 552104, 34274, 552111, 55400406110846, 500283, 550453, 500340, 500499, 550093, 550096, 34142, 34108, 34161, 34177, 34194, 34219, 34246, 34255, 550251, 34217, 34252, 34147, 34127, 550203, 550296, 550234, 550266, 34157, 550300, 550291, 550248, 34176, 34253, 550301, 34239, 34224, 34227, 34216, 34309, 550111, 550147, 550163, 550362, 550280, 550201, 550202, 550307, 550281, 550283, 550284, 550235, 550387, 550496, 550333, 550414, 550347, 550462, 550419, 550404, 550399, 550356, 550461, 550420, 550458, 550511, 552006, 552007, 552009, 552016, 550091, 552023, 552037, 550353, 550210, 550228, 550240, 552101, 550403, 550489, 550135, 550366, 550021, 552020, 552032, 550087, 550123, 550155, 550418, 550302, 550509, 550078, 550503, 552052, 540020, 540021, 552050, 541001, 550221, 550222, 550223, 550224, 552054, 550253, 552060, 552059, 552062, 550273, 550287, 550288, 550289, 552069, 550439, 550324, 550325, 552065, 550318, 550317, 550322, 552113, 552001, 550017, 550055, 552026, 550252, 552038, 552040, 552042, 550173, 34118, 552048, 34171, 34233, 55400406111117, 34319, 552031, 552030, 552053, 550293, 552071, 552073, 550043, 550141, 550115, 34110, 34121, 550058, 34062, 34104, 550180, 34145, 34272, 550211, 550229, 34238, 34249, 55400406111136, 550464, 550465, 550466, 550473, 550474, 550469, 550470, 55400406111636, 550099, 550175, 550378, 550415, 552116, 550457, 550039, 550067, 550424, 550233, 550006, 550411, 550396, 550428, 550003, 34063, 550101, 552049, 550151, 550440, 550512, 550110, 550192, 550352, 55400406111064, 550114, 550308, 550448, 552033, 552046, 500259, 510046, 500511, 552047, 550310, 34237, 550422, 550427, 550477, 550479, 550478, 550501, 552100, 550062, 550048, 550456, 552098, 55400406111276, 34395, 552082, 550425, 34370, 34361, 34369, 34365, 34360, 550226, 550225, 550407, 550232, 550249, 34284, 34346, 552061, 55400406111221, 55400406111210, 55400406111211, 55400406111437, 55400406111438, 55400406111457, 55400406111458, 552066, 554173, 500514, 550184, 552044, 550209, 550217, 550337, 55400406111026, 500504, 550102, 550433, 550524, 552004, 34286, 550270, 550486, 500517, 500519, 550024, 550206, 550207, 550214, 552083, 552084, 552099, 550144, 552024, 552027, 550294, 550338, 55400406111115, 552119, 550212, 500501, 500506, 550065, 500516, 550001, 550005, 550025, 550066, 550034, 550157, 550050, 550309, 550326, 550059, 550134, 550204, 550069, 550452, 550402, 550176, 550236, 550174, 550186, 550130, 550150, 550140, 550164, 550213, 550363, 550306, 550265, 550312, 550305, 550468, 500358, 550026, 550032, 34008, 550046, 34009, 34028, 550051, 34022, 34037, 34034, 34027, 34046, 34016, 34024, 34184, 34069, 34039, 34048, 552015, 550070, 34199, 34087, 34183, 34036, 34124, 552039, 34120, 34144, 34140, 34123, 34138, 34173, 34172, 34215, 34241, 34188, 34189, 34185, 34220, 34231, 34222, 34232, 34214, 34234, 34230, 34243, 34225, 34250, 34262, 34258, 34275, 34148, 34266, 34278, 34283, 55400406111183, 34287, 34271, 34288, 55400406110942, 34291, 34290, 34292, 55400406111085, 34298, 34297, 34299, 34300, 34302, 34305, 55400406111082, 34308, 34321, 55400406111099, 34328, 55400406111229, 34330, 34336, 34347, 34355, 34353, 34354, 55400406111895, 550510, 55400406111876, 55400406111644, 500411, 34021, 34076, 34094, 34154, 34213, 550449, 34320, 34322, 550085, 550327, 550346, 55400406111961, 55400406111960, 550367, 550377, 550368, 550372, 550380, 550370, 550371, 550369, 550379, 550376, 552072, 550351, 550358, 550360, 550357, 550359, 550365, 550339, 550342, 550340, 550341, 550348, 550349, 550350, 550131, 550139, 550145, 550167, 550166, 550171, 550178, 550197, 550198, 550267, 550275, 552078, 552079, 550344, 550345, 552080, 552087, 550364, 552088, 552089, 552093, 552092, 550373, 552096, 552095, 550405, 550406, 552102, 550435, 550450, 550454, 500531, 550002, 500529, 34014, 34013, 552003, 550018, 550075, 550073, 550074, 34109, 550113, 550112, 550095, 34113, 34139, 34167, 34261, 34178, 550238, 550254, 550279, 550303, 550268, 550336, 550290, 550408, 550409, 34323, 550395, 550421, 550417, 550426, 550442, 34311, 34314, 34310, 550472, 34312, 34316, 550022, 550152, 550041, 550100, 550447, 550128, 34228, 500266, 34015, 34197, 34210, 34268, 500387, 500005, 500062, 500418, 500453, 500530, 550008, 34247, 550010, 500515, 550097, 550036, 550172, 552011, 34011, 34020, 550082, 550071, 552028, 550094, 552018, 550148, 34155, 550136, 550142, 34107, 550177, 552045, 34141, 550205, 550215, 550237, 550247, 34182, 550282, 34204, 550311, 550328, 550332, 550393, 55400406110738, 552097, 55400406110740, 550401, 55400406110607, 34269, 552112, 34293, 34307, 34318, 55400406111033, 34329, 550467, 550487, 34364, 550494, 550499, 550502, 55400406111629, 34303, 34296, 500030, 500119, 500133, 500462, 55400406111352, 500508, 500509, 550118, 500505, 500538, 500500, 500503, 550015, 550194, 550047, 550106, 550020, 550086, 550023, 55400406111422, 550042, 550079, 550103, 550056, 550054, 552013, 552025, 550274, 550107, 34236, 550081, 550121, 34158, 550077, 34070, 550143, 34242, 550323, 550120, 550129, 34245, 550182, 550119, 550314, 550109, 550286, 550169, 550434, 34136, 552077, 34207, 55400406110840, 55400406111002, 550321, 34248, 34256, 34304, 500365, 500425, 500431, 500421, 500477, 33021, 500439, 33018, 550013, 550438, 500512, 550246, 550245, 550012, 550044, 550049, 550125, 550098, 552035, 550189, 550331, 552091, 550354, 550459, 550084, 552041, 500192, 550255, 550188, 34202, 550285, 500298, 34125, 34192, 550330, 550161, 55400406111118, 55400406111198, 34362, 34357, 34372, 550227, 550334, 550445, 550007, 550068, 550239, 550009, 550057, 550108, 550117, 550137, 550191, 550269, 552106, 552132, 554251, 554269, 554272, 554010, 554008, 554004, 554103, 554000, 556000, 554072, 554016, 554007, 554003, 554018, 554001, 554009, 554205, 554002, 554005, 554006, 556001, 556002, 554012, 554017, 554015, 554011, 554020, 554013, 554014, 554019, 554021, 554022, 554023, 554026, 554025, 554024, 554028, 554027, 554035, 554033, 554067, 554095, 554052, 554034, 554068, 554211, 554061, 554219, 554200, 554092, 554097, 554159, 554048, 554077, 554107, 554049, 554194, 554050, 554171, 554156, 554047, 554138, 554043, 554044, 554176, 554063, 554082, 554071, 554086, 554195, 556003, 556004, 554081, 554147, 556005, 554133, 554083, 554074, 554113, 554108, 554085, 554070, 554073, 554111, 554136, 554120, 554222, 554109, 554091, 554127, 554158, 554188, 554088, 554099, 554093, 554100, 554096, 554172, 554149, 554106, 554114, 554166, 554104, 554128, 554094, 554129, 554123, 554102, 554115, 554121, 554119, 554124, 554122, 554155, 554135, 554170, 554235, 554163, 554199, 554143, 554169, 554160, 554141, 554148, 554157, 554203, 554144, 554140, 554131, 554150, 554161, 554152, 554227, 554151, 554226, 554154, 554224, 554162, 554185, 554206, 554207, 554182, 554181, 554165, 554175, 554177, 554178, 554184, 554234, 554179, 554180, 554220, 554187, 554191, 554197, 554202, 554216, 554204, 554208, 554212, 554192, 554223, 554183, 554196, 554198, 554221, 554217, 554213, 554228, 554230, 554215, 554229, 554210, 554209, 554236, 554218, 554232, 554233, 554238, 554237, 554240, 552014, 510047, 510045, 550011, 550028, 550038, 550064, 550168, 552055, 550355, 550410, 550471, 550498, 34019, 550149, 550495, 550031, 550388, 34170, 550156, 550260, 550277, 34045, 550124, 550170, 550460, 550523, 34114, 34115, 34005, 550315, 500454, 550004, 550030, 550033, 550063, 552008, 550052, 552010, 550116, 550146, 550159, 550187, 550195, 550196, 550241, 550250, 550259, 550381, 550392, 550397, 500481, 500518, 550037, 550045, 552019, 550072, 550060, 550061, 552012, 550199, 550083, 550080, 552022, 550153, 550272, 552068, 550383, 550183, 550208, 550258, 550329, 550382, 550385, 550384, 550386, 550389, 550390, 550391, 550398, 550400, 550416, 552122, 552103, 552107, 34035, 34030, 34029;

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Ethiopia, France, FrenchPolynesia, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Macedonia, Malaysia, Mauritius, Mexico, Moldova, Montenegro, Montserrat, Morocco, Mozambique, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Papua Nw Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Rwanda, Saint Kitts, Saint Lucia, Saudi Arabia, Serbia, Sint Maarten (D, Slovakia, South Africa, South Korea, Spain, St.Pier,Miquel., Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

Recall record

Recalling firm: Philips North America Llc
Product type: Devices
Recall number: Z-0881-2026
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Cambridge, MA
Recall initiated: 2025-10-29

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-0881-2026 · Source: openFDA enforcement.