FDAJanuary 14, 2022device
1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A software defect in the camera control unit (CCU) 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.
What to do
FDA enforcement status: Ongoing
Brands named
stryker
UPCs
07613327420081
Recall history
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