Recall Z-1316-2008 ยท LMB Device, Digital Image Storage, Radiological
Stryker Endoscopy
Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving system.
| Date | Sep 11, 2008 (initiated Feb 15, 2008) |
| Status | Terminated |
| Reason | Patient Identification numbers and names may be applied to images from another patient due to a software issue. This failure mode can only occur when the pre-load function of the SDC ultra is used. |
| Root cause | Software design |
| Action | Stryker Endoscopy mailed Urgent Device Correction notices, dated February 14, 2008, to all consignees, and sales representatives will be supplied with a fix to distribute to the user base. |
| Quantity | 814 units distributed |
| Distribution | Worldwide distribution: USA, Canada, Greece, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.