MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, cor
FDA device recall Z-1211-2013 · posted 2013-05-01 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
- Action taken
- GE Healthcare sent an Urgent Medical Device Correction letter dated April 23, 2013, to all affected customers. The letter informed customers of a potential safety issue due to leakage from gradient coolant lines. Consignees were instructed to monitor the floor for leakage and continue to use if leakage is not observed. If leakage is observed consignees are instructed to stop using the system and notify their local service representative. GE Healthcare will correct all affected scanners by providing an update at no cost. Customers with questions were instructed to contact their local service representataive. For questions regarding this recall call 262-513-4122.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 70
- Distribution
- Worldwide Distribution - USA including AL, CA, CO, FL, ID, IL, MA, NH, NJ, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI; Worldwide: Argentina, Australia, Austria, Brazil, Canada, Chile, Denmark, Egypt,
- Date initiated
- 2013-03-28
- Date posted
- 2013-05-01
- Date terminated
- 2013-10-25
- 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 |
|---|---|---|
| MSK EXTREME MR SCANNER, MODEL AA5000 (K080048) | Oni Medical Systems, Inc. | 2008-02-06 |