Optima 1.5T MR430s MR Scanner, a diagnostic imaging device
FDA device recall Z-1928-2016 · posted 2016-06-08 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.
- Action taken
- GE Healthcare sent an " Urgent Medical Device Correction" letter dated May 9, 2016, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Detail, Product Correction & Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 101
- Distribution
- US: AL, AZ, CA, CO, FL, ID, IL, IA,ME, NE, NV,NH, NJ, NY, NC, OH, PA, SC, SD, TN, TX, UT,VA, WA, WI. OUS: Argentina Australia Austria Brazil Canada Chile Colombia Denmark Egypt Finland France Germany
- Date initiated
- 2016-05-09
- Date posted
- 2016-06-08
- Date terminated
- 2018-07-11
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTIMA MR 430S (K123068) | Ge Medical Systems, LLC | 2012-11-13 |