Class II FDA device recall · Z-0763-2024

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.

Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB1 - ARDINT059002C, EPS MB1 TR - ARDINT059000A, EPS MB1 TR - ARDINT059000C, EPS MB3 - ARDINT059003A, EPS MB3 - ARDINT059003C, EPS MB3 TR - ARDINT059001A, EPS MB3 TR - ARDINT059001C, OPT MBAT - ARD568210010A, OPT MBAT - ARD568210010C, PWD30 DUAL - ARD267800310C, PWD30 DUAL - ARD267800330A, PWD30 DUAL - ARD267800330C, PWD30 DUAL - ARD267800340A, PWD30 DUAL - ARD267800340C, PWD30+DF - ARD268300170A, PWD30+DF - ARD568424110A, PWD30+DF - ARD568424110C, PWD30+DF - ARD568424114A, PWD30+DF - ARD568424114C, PWD30+DF - ARD568424511A, PWD30+DF - ARD568424511C, PWD30+DF - ARD568424512A, PWD30+DF - ARD568424512C, PWD30+DF - ARD568424513A, PWD30+DF - ARD568424513C, PWD30+DF - ARD568484114A, PWD30+DF - ARD568484114C, PWD30+DF - ARD569424110A, PWD30+DF - ARD569424110C, PWD30+DF - ARD569424114A, PWD30+DF - ARD569424114C, PWD30+DF - ARD569424511A, PWD30+DF - ARD569424511C, PWD30+DF - ARD569424512A, PWD30+DF - ARD569424512C, PWD30+DF - ARD569424513A, PWD30+DF - ARD569424513C, PWD30+DF - ARD569484114A, PWD30+DF - ARD569484114C, PWD30+DF - ARDPWD208008A, PWD30+DF - ARDPWD208008C, PWD30+DF - ARDPWD209000A, PWD30+DF - ARDPWD209000C, PWD30+DF - ARDPWD209009A, PWD30+DF - ARDPWD209009C, PWD30+DF - ARDPWD239013A, PWD30+DF - ARDPWD239013C, PWD30+DF - ARDPWD239014A, PWD30+DF - ARDPWD239014C, PWD30+DF - ARDPWD239015A, PWD30+DF - ARDPWD239015C, PWD30+DF - ARDPWD239031A, PWD30+DF - ARDPWD239031C, PWD30+DF - ARDPWD239032A, PWD30+DF - ARDPWD239032C, PWD30+DF - ARDPWD239033A, PWD30+DF - ARDPWD239033C, PWD30+SF - ARD568414110A, PWD30+SF - ARD568414110C, PWD30+SF - ARD568414114A, PWD30+SF - ARD568414114C, PWD30+SF - ARD568414511A, PWD30+SF - ARD568414511C, PWD30+SF - ARD568414512A, PWD30+SF - ARD568414512C, PWD30+SF - ARD568414513A, PWD30+SF - ARD568414513C, PWD30+SF - ARD568474114A, PWD30+SF - ARD568474114C, PWD30+SF - ARD569414110A, PWD30+SF - ARD569414110C, PWD30+SF - ARD569414114A, PWD30+SF - ARD569414114C, PWD30+SF - ARD569414511A, PWD30+SF - ARD569414511C, PWD30+SF - ARD569414512A, PWD30+SF - ARD569414512C, PWD30+SF - ARD569414513A, PWD30+SF - ARD569414513C, PWD30+SF - ARD569474114A, PWD30+SF - ARD569474114C, PWD30+SF - ARDPWD208009A, PWD30+SF - ARDPWD208009C, PWD30+SF - ARDPWD209001A, PWD30+SF - ARDPWD209001C, PWD30+SF - ARDPWD209002A, PWD30+SF - ARDPWD209002C, PWD30+SF - ARDPWD209010A, PWD30+SF - ARDPWD209010C, PWD30+SF - ARDPWD209011A, PWD30+SF - ARDPWD209011C, PWD30+SF - ARDPWD239016A, PWD30+SF - ARDPWD239016C, PWD30+SF - ARDPWD239017A, PWD30+SF - ARDPWD239017C, PWD30+SF - ARDPWD239018A, PWD30+SF - ARDPWD239018C, PWD30+SF - ARDPWD239034A, PWD30+SF - ARDPWD239034C, PWD30+SF - ARDPWD239035A, PWD30+SF - ARDPWD239035C, PWD30+SF - ARDPWD239036A, PWD30+SF - ARDPWD239036C, PWD30+SHIP - ARD268400080A, PWD30+SHIP - ARD268400080C, PWD33 S - ARD267800200A, PWD33 S - ARD267800200C, PWD33+DF - ARD568424710A, PWD33+DF - ARD568424710C, PWD33+DF - ARD568424714A, PWD33+DF - ARD568424714C, PWD33+DF - ARD568424751A, PWD33+DF - ARD568424751C, PWD33+DF - ARD568424752A, PWD33+DF - ARD568424752C, PWD33+DF - ARD568424753A, PWD33+DF - ARD568424753C, PWD33+DF - ARD568424755A, PWD33+DF - ARD568424755C, PWD33+DF - ARD568424758A, PWD33+DF - ARD568424758C, PWD33+DF - ARD569424710A, PWD33+DF - ARD569424710C, PWD33+DF - ARD569424714A, PWD33+DF - ARD569424714C, PWD33+DF - ARD569424751A, PWD33+DF - ARD569424751C, PWD33+DF - ARD569424752A, PWD33+DF - ARD569424752C, PWD33+DF - ARD569424753A, PWD33+DF - ARD569424753C, PWD33+DF - ARD569424755A, PWD33+DF - ARD569424755C, PWD33+DF - ARD569424758A, PWD33+DF - ARD569424758C, PWD33+SF - ARD568414710A, PWD33+SF - ARD568414710C, PWD33+SF - ARD568414714A, PWD33+SF - ARD568414714C, PWD33+SF - ARD568414751A, PWD33+SF - ARD568414751C, PWD33+SF - ARD568414752A, PWD33+SF - ARD568414752C, PWD33+SF - ARD568414753A, PWD33+SF - ARD568414753C, PWD33+SF - ARD568414755A, PWD33+SF - ARD568414755C, PWD33+SF - ARD568414758A, PWD33+SF - ARD5684147

Why it was recalled

A potential for a light system to fall in the operating room.

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

All systems affected.  UDI-DI:             3700712405847  3700712406134  03700712405977 3700712403133  03700712403140  03700712402259  03700712402266  03700712402273  03700712404277              03700712403232    03700712403454  03700712402471  03700712402488  03700712402495        3700712403010  03700712403027  03700712403744  03700712403751  03700712403768  3700712403478              03700712403249      03700712403256  03700712403263  03700712402501  03700712402518  03700712402525          ¿3700712406103  03700712403157  03700712403164  03700712403942  03700712403959  03700712403966                    03700712403034  03700712403041  03700712403775  03700712403782  03700712403799  03700712403805                   03700712405779 03700712403065  03700712403072  03700712402136  03700712402143  03700712402150          03700712402570  03700712401856  03700712401863  03700712401870                            03700712402655    03700712403461  03700712403393    03700712406011 03700712402778    03700712402426  03700712402433  03700712402440        03700712402044  03700712402051  03700712402068          03700712402945  03700712402952  03700712403539  03700712403546  03700712403553          03700712402549                      03700712402662      03700712403270  03700712403287  03700712411947 03700712402785  03700712402792      03700712402358    03700712402457  03700712402464      03700712404376    03700712401979    03700712402075  03700712402082      03700712403089  03700712403096  03700712402167  03700712402174  03700712403836  03700712403843            03700712402587  03700712401887  03700712401894                              03700712402693  03700712403386    03700712402853    03700712404413  03700712402969  03700712402976  03700712403560  03700712403577  03700712403584  03700712403591            03700712402556                          03700712402686  03700712403379    03700712402839       03700712402747  03700712403058  03700712402112  03700712402129  03700712403812  03700712403829            03700712402563  03700712401832  03700712401849   03700712414153                          03700712403362      03700712404314  03700712402860    03700712402938  03700712403492  03700712403508  03700712403515  03700712403522            03700712402532                        03700712402709  03700712403355      03700712404345  03700712402846    03700712404390    03700712402877    03700712404284  03700712405762 03700712403119  03700712402204  03700712402211  03700712402228          03700712403218  03700712404192  03700712404208  03700712402327          03700712402631  03700712401924  03700712401931  03700712401948                                          03700712403294  03700712403409    03700712403485 03700712405823 03700712406028   03700712405830 03700712402808    03700712402907    03700712402365  03700712402372  03700712402389        03700712401986  03700712401993  03700712402006        03700712402990  03700712403690  03700712403706  03700712403713          03700712403188  03700712404062  03700712404079  03700712404086          03700712402600                                    03700712402679      03700712403300  03700712403317  03700712403324    03700712403430    03700712411954 03700712402815  03700712402822      03700712402396  03700712402402  03700712402419        03700712404383    03700712402013  03700712402020  03700712402037        03700712403126  03700712402235  03700712402242  03700712403928  03700712403935            03700712403225  03700712402334  03700712402341  03700712404215  03700712404222            03700712402648  03700712401955  03700712401962                                                03700712402914    03700712403003  03700712402099  03700712402105  03700712403720  03700712403737            03700712403195  03700712402280  03700712402297  03700712404093  03700712404109            03700712402617                                            03700712402723  03700712402716  03700712403416    03700712403423      03700712402754  03700712402921    03700712403102  03700712402181  03700712402198  03700712403850  03700712403867            03700712403201  03700712402303  03700712402310  03700712404123  03700712404130            03700712402624  03700712401900  03700712401917                                03700712413385                03700712403348      03700712404307  03700712404352  03700712402891    03700712404406     03700712402983  03700712403607  03700712403614  03700712403621  03700712403638            03700712403171  03700712403973  03700712403980  03700712403997  03700712404000            03700712402594                                            03700712403331      03700712404338  03700712402884       03700712402730  03700712403447      03700712402761     03700712403874  03700712403881  03700712403898  03700712403904  03700712403911            03700712404147  03700712404154  03700712404161  03700712404178  03700712404185            03700712404239  03700712404246  03700712404253  03700712404260                                                     03700712404291  03700712403645  03700712403652  03700712403669  03700712403676  03700712403683            03700712404017  03700712404024  03700712404031  03700712404048  03700712404055            03700712404116                                              03700712404321    03700712404369  03700712404451    03700712404499    03700712404444    03700712404482    03700712404437    03700712404475    03700712404420    03700712404468      03700712404529  03700712404536  03700712404567  03700712404574          03700712404505  03700712404512  03700712404543  03700712404550                  03700712413392               03700712401795  03700712401801              03700712401818  03700712401825

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

US Nationwide. Global Distribution.

Recall record

Recalling firm: Getinge Usa Sales Inc
Product type: Devices
Recall number: Z-0763-2024
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Wayne, NJ
Recall initiated: 2023-11-08

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-0763-2024 · Source: openFDA enforcement.