Recall Z-1755-2019— 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: K982955. Product: Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-saving design.. 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
Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-saving design.
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.