Recall Z-1590-2010 ยท LMB Device, Digital Image Storage, Radiological
Stryker Endoscopy
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.
| Date | May 10, 2010 (initiated Oct 23, 2009) |
| Status | Terminated |
| Reason | Video device is not able to assign the correct time/date stamp. |
| Root cause | Device Design |
| 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 is |
| Quantity | 12896 devices |
| Distribution | US government facilities and other US domestic consignees(nationwide), and to foreign countries |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.