Recall Z-0954-2015— GE Healthcare
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, initiated 2014-12-08, terminated 2016-02-03. It names one FDA 510(k) clearance: K993090. Product: GE Healthcare, Proteus XR/a with wall stand model number 600-0301.. Reason: GE Healthcare has recently become aware of a potential safety issue involving the breakage of the two steel cables which support the bucky device in the wall stand of Proteus XR/a X-ray imaging systems. No injuries reported..
- Recalling firm
- GE Healthcare
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-08
- Terminated
- 2016-02-03
- 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, Proteus XR/a with wall stand model number 600-0301.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue involving the breakage of the two steel cables which support the bucky device in the wall stand of Proteus XR/a X-ray imaging systems. No injuries reported.
Data sourced from openFDA. This site is unofficial and independent of the FDA.