Reported Mar 16, 2022 · Ongoing
1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear…
Stryker Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Corporation · 5900 Optical Ct · San Jose, CA · 95138-1400
Is this the product you have?
- 1688 Camera Control Unit (CCU)
- Catalog number1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used
- Lot codes and dates
- All serial numbers of 1688 CCU
- UDI07613327420081
- with Software Revisions
3.0.64.0.13and 4.0.18
- Amount recalled
- 11,955
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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