GE Healthcare, 3.0T Signa MR750 (Marketing Name: GE Discovery MR750) Product Usage: The GE Sigma MR750 System is a whole
FDA device recall Z-3122-2011 · posted 2011-09-01 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has become aware of two potential safety issues associated with MR products (Optima MR450w, Discovery MR450, Discovery MR750, Brivo MR355, Optima MR360) that may impact patient safety. 1) Inline post-processed (i.e. automated post-processing) image locations are not correctly annotated under some conditions. 2) Reference images displayed in Functool FiberTrak do not match with
- Action taken
- GE Healthcare sent an "Urgent Medical Device Correction" letter dated July 27, 2011 to customers with affected systems. The letter described the recalled product, safety issues and recommended actions to be taken. The letter provided immediate mitigation (Safety Instuctions) that address each issue. The letter states that the recalling firm will contact customers to arrange to provide a software upgrade to all affected systems at no cost. For any questions concerning this notification contact your local service representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 171
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of: AL, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, LA,ME, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN
- Date initiated
- 2011-07-29
- Date posted
- 2011-09-01
- Date terminated
- 2013-08-07
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIGNA 3.0T MR750 SYSTEM (K081028) | Ge Medical Systems, LLC | 2008-04-25 |