Signa Ovation, 0.35T MR Systems (MFO 1-4). Indicated for use as a diagnostic imaging device to produce transverse, sagit
FDA device recall Z-0426-2011 · posted 2010-11-19 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- If the lateral table adjustment crank handle breaks off, it has sufficient attractive force to the magnet and may result in patient injury.
- Action taken
- Consignees were sent on 8/23/10 a GE "Urgent Medical Device Correction" letter dated August 20, 2010. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Managers and Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, and Contact Information. Customers were asked to discontinue use of their MR system and to contact their local service representative, if the lateral table adjustment crank handle on the table becomes loose.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 202
- Distribution
- Worldwide Distribution -- USA, including states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, LA, KS, KY, LA, MD, MA, MI, MN, MS,MO,MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA,
- Date initiated
- 2010-08-23
- Date posted
- 2010-11-19
- Date terminated
- 2012-07-13
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (K033504) | General Electric Co. | 2003-11-25 |
| SIGNA MFO/I MAGNETIC RESONANCE SYSTEM (K002611) | GE Medical Systems | 2000-10-31 |