Stryker Corporation Recall 89515
Description: 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.
Stryker Corporation Recall 89515 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0728-2022 |
| Event ID | 89515 |
| Event Description | 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. |
| Product Type | Devices |
| 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 |
| Quantity | 11,955 |
| Recall 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. |
| Device Classification | 20220316 |
| Device Code Info | All serial numbers of 1688 CCU, UDI: 07613327420081, with Software Revisions: 3.0.6, 4.0.13, and 4.0.18 |
| Center Classification Date | 20220307 |
| Recall Initiation Date | 20220114 |
| Recalling Firm | Stryker Corporation |
| Initial Notification | Letter |
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