Reported Apr 1, 2015 · Terminated
GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE,…
GE Healthcare
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
GE HealthcareSIGNA 1.5T TWINSPEEDSIGNA INFINITY MRISYSTEMSIGNA 3.0T INFINITY WITH EXCITESIGNA 3.0T WITH EXCITESIGNA EXCITE 1.5TSIGNA EXCITE 3.0TGE 1.5T AND 3.0T SIGNA HDX MR SYSTEMDiscovery MR750 3.0TDiscovery MR450 1.5TDiscovery MR750w 3.0TOptima MR450w 1.5TSIGNA ContourBrivo MR355Optima MR360GE 1.5T SIGNA HDE MR SYSTEMSigna Openspeed 0.7T MR SYSTEMVectraSIGNA 0.35T OVATION WITH EXCITESIGNA 0.2T PROFILE With EXCITE MRI Systems
- Lot codes and dates
- Mfg Lot or Serial # System ID8
697 of 697 codes
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
1175 of 75 codes
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
12107 of 107 codes
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
GEHANGWEI1,066 of 1,066 codes
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
479 of 479 codes
002003-1210-16082427040038000000HDMR57570824270400920002005-0914-108242704005300000308162MR708242704013700000000361M2608242704009500001307FMM07W08242704015400000000768M2208242704010400000287879MR108242704007600000015991GQ308242704008300000011374GQ608242704007000000000179M2208242704009300000279159MR808242704007200000937BD5EE008242704009800001318FMM00608242704016100000005586M2308242704015600000293676MR308242704010600000306732MR908242704013300000292090MR808242704008800000301928MR808242704011300000267977MR708242704005400000005814M2908242704015900000001408M2408242704011200000013807GQ308242704006700001302FMM04F08242704014800000006205M2908242704016200001201FMM08908242704015300000301753MR008242704012100001046XF500608242704010500000002805M2008242704012900001302FMM04A082427040114
- Mfg Lot or Serial # System ID
- Amount recalled
- 9,369 (2,937 US, 6,432 OUS).
Where it was sold
Why it was recalled
GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new GE Healthcare recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.