GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices
FDA device recall Z-0260-2016 · posted 2015-11-10 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
- Action taken
- GE Healthcare sent an Urgent Medical Device Correction letter dated August 31, 2015. The letter was addressed to Hospital Administrators/Risk Managers, Radiology Department Managers, & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- OUO
- Quantity affected
- 17
- Distribution
- Worldwide Distribution - US: Nationwide including DC, PR and GU and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOSNIA HERZEGOVINA, BRAZIL,
- Date initiated
- 2015-08-31
- Date posted
- 2015-11-10
- Date terminated
- 2018-09-07
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIGNA PET/MR (K142098) | Ge Medical Systems, LLC | 2014-11-24 |