Reported Nov 19, 2014 · Terminated
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA,…
GE Healthcare, LLC
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, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS
- Product UsageThe GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy
- Lot codes and dates
510 of 510 codes
21111DUKECCDSV670NM21189DUKEDMP670NM21223307362D67021224660890D67021079091026702200000000103BH2091026325900000000124BH88309232784300000000129BH78309271950000000087514HL68309296282900000097761HL18309557238200000333837HM38309109640221215100039NU0221229210002NU1121220BY4033NM012116682426070031212138242604005221222082426040053212310824260700342123008242608002221226TP0007NU0221155IE1018MN03092302HL9KW1001NM01092303HL7KW1112NM04092307HL8KW1112NM0321148ZWL063000000093649HL2QA1064NM0121173RU2581NM0121190RU7174NM0100000290644HM4RU1493NM0100000322039HM9SA1006NM01
- Amount recalled
- 255
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
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.
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