Boston Scientific SpyGlass Light Cable Reference Number: 4621 UPN M00546210
FDA device recall Z-0698-2007 · posted 2007-03-31 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Light Degradation in transmission-A film may deposit on the front face and limit transmission of light
- Action taken
- Boston Scientific notified accounts by letter dated 2/1/07 requesting return of product.
- Root cause
- Other
- Status
- Terminated
- Product code
- EQH
- Quantity affected
- 13 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
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LUXTEC FIBEROPTIC CABLES (K864387) | Luxtec Corp. | 1987-05-22 |