Recall Z-1590-2010
Stryker Endoscopy · initiated October 23, 2009
Product
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.
Codes / lots: Product Name: SDC HD units and SDC HDi units Model Nuumbers: 240-050-888 and 240-050-888i Code: All SDC HD and SDC HDi units
Reason for recall
Video device is not able to assign the correct time/date stamp.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-1590-2010
- Initiated
- October 23, 2009
- Posted by FDA
- May 10, 2010
- Terminated
- February 17, 2011
- Product code
- LMB – Device, Digital Image Storage, Radiological
- Quantity
- 12896 devices
- Distribution
- US government facilities and other US domestic consignees(nationwide), and to foreign countries
- Recalling firm
- Stryker Endoscopy, San Jose, CA