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.
Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 781262 (2) 781261
Why it was recalled
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
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
UDI-DI: (1) 781262 (01)00884838068445(21); (2) 781261 (01)00884838068438(21) Serial Numbers: Serial Number 77008 77000 77004 77001 77019 77010 77014 77007 77002 77016 77131 77070 77124 77144 77172 77074 77048 77177 77178 77181 77031 77047 77134 77050 77051 77060 77194 77034 77037 77038 77057 77072 77075 77078 77084 77085 77086 77092 77101 77110 77156 77157 77035 77111 77119 77167 77183 77185 77187 77188 77195 77196 77198 77199 77202 77052 77053 77054 77055 77056 77064 77065 77066 77067 77068 77069 77105 77125 77126 77135 77136 77137 77138 77139 77148 77141 77030 77032 77033 77036 77042 77043 77044 77049 77059 77061 77071 77083 77087 77088 77090 77091 77093 77097 77100 77106 77107 77112 77115 77118 77120 77121 77128 77129 77143 77151 77155 77158 77161 77162 77190 77191 77201 77166 77045 77063 77109 77117 77123 77081 77147 77113 77168 77169 77122 77154 77046 77094 77130 77062 77140 77039 77040 77058 77114 77127 77159 77160 77171 77179 77180 77182 77150 77041 77103 77203
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.
Recall record
- Recalling firm
- Philips North America Llc
- Product type
- Devices
- Recall number
- Z-1846-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Cambridge, MA
- Recall initiated
- 2024-05-03
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-1846-2024 · Source: openFDA enforcement.