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Terminated

An Imaging device for medical procedures, to provide surgeons or operating room personnel the ability to capture still images and to record video during the surgical procedures in various file formats. Images can be transferred to external media.

FDA Recall Z-1590-2010 · Posted 2010-05-10

Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeLMB
Date Initiated2009-10-23
Date Terminated2011-02-17
Product Quantity12896 devices

Reason for Recall

Video device is not able to assign the correct time/date stamp.

Firm Action

Stryker Endoscopy has notified the 2865 domestic consignees affected by the device correction. The notification was mailed to affected consignees and their corresponding sales representatives. It included two mailings of the Urgent: Device Correction notice, SDC HD 3.0z correction software, and a SDC HD upgrade dongle. 100% of consignees have been contacted and notified of the device correction needed. The effectiveness of the correction has been tracked via acknowledgement cards mailed, faxed, or emailed. The local Stryker Sales Representative will install a software upgrade to fix this issue. Additional questions should be directed to the firm's Customer Service at (800)624-4422 or (408)754-2039.

Root Cause

Device Design

Distribution Pattern

US government facilities and other US domestic consignees(nationwide), and to foreign countries

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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