Z-1602-2020 Class II Terminated
FDA device recall Z-1602-2020 was initiated by Stryker Communications on October 11, 2019 and is designated Class II. 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 … The recall status is terminated (terminated October 18, 2022). Affected quantity: 1415 Surgical Lights.
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2020
- Initiation Date
- October 11, 2019
- Termination Date
- October 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1415 Surgical Lights
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.
Distribution Pattern
US: Nationwide OUS: Canada
Code Information
Serial Number Range: 091316 70016 through 083117-73252