16
Mar
2022

Recall – Software error results in incorrect camera display orientation

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0

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

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