Recall Z-2590-2021— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2021-06-24, terminated 2023-06-14. It names one FDA 510(k) clearance: K210982. Product: AMX Navigate Mobile X-Ray System. Reason: An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-06-24
- Terminated
- 2023-06-14
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
AMX Navigate Mobile X-Ray System
Reason for recall
An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.