Company: Stryker Corporation
Date of Enforcement Report: 3/16/2022
Class II
PRODUCT
1688 Camera Control Unit (CCU), Catalog number: 1688010000 1688 Pendulum Camera Heads
Recall Number: Z-0728-2022
REASON
A software defect has been identified in the 1688 Camera Control Unit (CCU) that will cause the image on the monitor to flip upside-down into an incorrect orientation. The potential of harms are conversion to open procedure, additional medical intervention, or a revision surgery.
RECALLING FIRM/MANUFACTURER
Stryker Corporation on 1/14/2022. Voluntary: Firm initiated
VOLUME OF PRODUCT IN COMMERCE
9497
DISTRIBUTION
U.S. Nationwide and International