Recall Z-0697-2007 ยท KOG
Boston Scientific Corporation
Boston Scientific SpyGlass Ocular Reference Number: 4604 UPN M00546040
| Date | Mar 31, 2007 (initiated Feb 7, 2007) |
| Status | Terminated |
| Reason | SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe |
| Root cause | Other |
| Action | Boston Scientific notified accounts by letter dated 2/1/07 requesting return of product. |
| Quantity | 12 units |
| Distribution | Nationwide Distribution --- including states of CA, CO, FL, OH, MA, MN, MO NY, PA, SC,TX, and WA . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052194 | SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR Boston Scientific Corp, Aug 24, 2005 |