Stryker Corporation: 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/end

Is my product affected?

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.

• UPC 07613327420081

Check against the official notice below — it lists the full affected range.

What happened

Stryker Corporation is recalling the 1688 Camera Control Unit (CCU), a device used in laparoscopic and endoscopic procedures such as general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery. A software defect in the device can cause the image displayed on the monitor to flip upside-down into an incorrect orientation. This defect could potentially lead to conversion to an open procedure, additional medical intervention, or revision surgery. The recall affects 11,955 units worldwide, distributed across the United States (including Puerto Rico) and numerous international countries.

The recalled devices include all serial numbers of the 1688 CCU with UDI 07613327420081 that contain Software Revisions 3.0.6, 4.0.13, or 4.0.18. The source document does not specify a remedy or any actions an affected consumer should take.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

Reason for recall: 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. 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 Lot/code info: All serial numbers of 1688 CCU, UDI: 07613327420081, with Software Revisions: 3.0.6, 4.0.13, and 4.0.18

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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