AMX Navigate Mobile X-Ray System
FDA device recall Z-2590-2021 · posted 2021-09-29 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.
- Action taken
- On June 24, 2021 the firm contacted the facilities that received the device via email. An AMX Navigate system was provided to 3 healthcare facilities for evaluation under an agreement with GE Healthcare. While at the healthcare facilities, these systems remained under the ownership of GE Healthcare. After one of the healthcare facilities alerted GE Healthcare to a potential issue with its system, GE Healthcare removed the system from the 3 healthcare facilities in order to perform a detailed engineering analysis as part of its root cause investigation. These 3 systems have not been returned to the healthcare facilities and remain in GE Healthcare s possession.
- Root cause
- Process control
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 3 units
- Distribution
- Domestic Distribution Only
- Date initiated
- 2021-06-24
- Date posted
- 2021-09-29
- Date terminated
- 2023-06-14
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMX Navigate (K210982) | Ge Medical Systems, LLC | 2021-04-28 |