Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937, 2282853, 2282860, 2282880, 2352129, 23
FDA device recall Z-0170-2008 · posted 2007-11-07 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Incorrect patient positioning; when moving the patient into the bore may lead to wrist and hand injury.
- Action taken
- Field Modification Instruction : FMI 67631 (DEC 2006) was communicated directly to the GE Healthcare service engineers who provide the modification at the customer site. Corrections were performed in DEC 2006
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 163
- Distribution
- Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, FL, ID, IL, IN, KS, KY, LA, MD, MO, MS, MT, NJ, NY, OH, OK, PA, SD, VA, and WA, and countries of United Arab Emirats, Argenti
- Date initiated
- 2006-12-31
- Date posted
- 2007-11-07
- Date terminated
- 2007-12-11
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIGNA MFO/I MAGNETIC RESONANCE SYSTEM (K002611) | GE Medical Systems | 2000-10-31 |