Z-0692-2018 Class II Terminated
FDA device recall Z-0692-2018 was initiated by Stryker Communications on January 26, 2018 and is designated Class II. Reason for recall: The mounts on the monitor may have an insufficient (missing or incomplete) weld. The recall status is terminated (terminated March 19, 2019). Affected quantity: 850.
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- January 26, 2018
- Termination Date
- March 19, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 850
Product Description
Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
Reason for Recall
The mounts on the monitor may have an insufficient (missing or incomplete) weld.
Distribution Pattern
Distribution was made to medical facilities nationwide, including government and military distribution. Foreign distribution was made to Canada, Belgium, China, United Kingdom, UAE, France, Germany, Spain, Japan, Ecuador, and Russia.
Code Information
United States and Canada: Serial numbers DFP-075-0307-0001 to DFP-075-1014-0230; International: Serial numbers 6145060-O11628 to 6176090-V14102