Recall Z-0728-2022 ยท GCJ Laparoscope, General & Plastic Surgery
Stryker Corporation
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.
| Date | Mar 7, 2022 (initiated Jan 14, 2022) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software in the Use Environment |
| Action | Medical Safety Notification was issued On January 28, 2022. This is Part 1 of 2. Customer Instructions on January 28,2022 state: Check inventory to see if you have a 1688 Pendulum Camera. NO PRODUCT RETURN IS NECESSARY. Return the business reply form by email to endorecall@stryker.com to confirm receipt of this notification. Maintain awareness of this communication internally until part 2 of 2 of this field action is conducted. If you have any questions or concerns, please email endorecall@stryker.com. These solutions are temporary while Stryker Endoscopy develops a software update to t |
| Quantity | 11,955 |
| Distribution | Worldwide distribution. US nationwide including Puerto Rico. OUS: BR, AE, NL, IN, FR, ES, HK, IT, GB, CO, PE, MY, TH, CA, JP, MX, AR, NP, SG, PH, ZA, CL, KR, CN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182160 | 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K C Stryker, Nov 5, 2018 |