Recall Z-1602-2020— Stryker Communications
Class II · Terminated
Class II FDA medical device recall by Stryker Communications, initiated 2019-10-11, terminated 2022-10-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000. Reason: The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may result in an insufficient mount force that causes the surgical light to fall. If the suspension of the surgical light falls, it may potentially cause serious injuries to Health Care Providers and/or patients..
- Recalling firm
- Stryker Communications
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-11
- Terminated
- 2022-10-18
- Firm location
- Flower Mound, TX, United States
Product description
Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000
Reason for recall
The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may result in an insufficient mount force that causes the surgical light to fall. If the suspension of the surgical light falls, it may potentially cause serious injuries to Health Care Providers and/or patients.
Data sourced from openFDA. This site is unofficial and independent of the FDA.