Recall Z-1752-2019— GE Healthcare, LLC
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2019-03-29, terminated 2021-04-15. It names one FDA 510(k) clearance: K993090. Product: Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements. The system provides exceptional image quality, high frequency X-ray generation, easy patient positioning, intuitive operator control and minimal system maintenance.. Reason: There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-29
- Terminated
- 2021-04-15
- 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
Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements. The system provides exceptional image quality, high frequency X-ray generation, easy patient positioning, intuitive operator control and minimal system maintenance.
Reason for recall
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
Data sourced from openFDA. This site is unofficial and independent of the FDA.