FDA Device recall Z-0728-2022
1688 Camera Control Unit (CCU), Catalog number:1688010000
- FDA Device
- Class II
- ongoing
- Published 2022-03-16
On 2022-03-16 the FDA classified a Class II recall of 1688 Camera Control Unit (CCU), Catalog number:1688010000 by Stryker, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0728-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-14 |
| Published | 2022-03-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stryker |
| Distribution | US |
Product
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.
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.
Identifiers
| code_info | All serial numbers of 1688 CCU, UDI: 07613327420081, with Software Revisions: 3.0.6, 4.0.13, and 4.0.18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0728-2022%22
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