Boston Scientific SpyGlass Visualization Probe Reference Number: 4603 UPN M00546030
FDA device recall Z-0696-2007 · posted 2007-03-31 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe
- Action taken
- Boston Scientific notified accounts by letter dated 2/1/07 requesting return of product.
- Root cause
- Other
- Status
- Terminated
- Product code
- KOG
- Quantity affected
- 115 units
- Distribution
- Nationwide Distribution --- including states of CA, CO, FL, OH, MA, MN, MO NY, PA, SC,TX, and WA .
- Date initiated
- 2007-02-07
- Date posted
- 2007-03-31
- Date terminated
- 2007-11-15
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR (K052194) | Boston Scientific Corp | 2005-08-24 |