Recall Z-1407-2015— GE Healthcare
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, initiated 2014-12-19, terminated 2015-04-29. It names one FDA 510(k) clearance: K142383. Product: GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx. Reason: An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec..
- Recalling firm
- GE Healthcare
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-19
- Terminated
- 2015-04-29
- 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
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
Reason for recall
An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
Data sourced from openFDA. This site is unofficial and independent of the FDA.