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.
Recall
- Recall Number
- Z-1590-2010
- Event Number
- 54683
- Firm
- Stryker Endoscopy
- FEI Number
- 2936485
- Product Code
- LMB
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- October 23, 2009
- Posted
- May 10, 2010
- Terminated
- February 17, 2011
- Address
- 5900 Optical Ct, San Jose, CA, 95138-1400
Description
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.
Video device is not able to assign the correct time/date stamp.
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.
US government facilities and other US domestic consignees(nationwide), and to foreign countries
12896 devices