An Imaging device for medical procedures, to provide surgeons or operating room personnel the ability to capture still i

FDA device recall Z-1590-2010 · posted 2010-05-10 · Terminated

Recall details

Recalling firm

Stryker Endoscopy

Reason for recall

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

Action taken

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

Status

Terminated

Product code

LMB

Quantity affected

12896 devices

Distribution

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

Date initiated

2009-10-23

Date posted

2010-05-10

Date terminated

2011-02-17

Location

San Jose, CA