Recall Z-0768-2016— GE Medical Systems, LLC
Class II · Terminated
Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2015-12-23, terminated 2016-09-07. It names one FDA 510(k) clearance: K142383. Product: GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.. Reason: Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person..
- Recalling firm
- GE Medical Systems, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-23
- Terminated
- 2016-09-07
- 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, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
Reason for recall
Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.
Data sourced from openFDA. This site is unofficial and independent of the FDA.