Recalls / —
—#50493
Product
Boston Scientific SpyGlass Camera Ref Number: 4610 UPN M00546100
- FDA product code
- KOG
- 510(k) numbers
- K971373
- Affected lot / code info
- Lot Numbers: 061005, 061006, 061007, 061009, 061010, 0161011, 061012, 610130, 61014, 061015, 061016, 061017
Why it was recalled
A teal "bloom"/ glare on the subject image during high light conditions.
Root cause (FDA determination)
Other
Action the firm took
Boston Scientific notified accounts by letter dated 2/1/07 requesting return of product.
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 1 Boston Scientific Pl, Natick, Massachusetts 01760-1536
Distribution
- Distribution pattern
- Nationwide Distribution --- including states of CA, CO, FL, OH, MA, MN, MO NY, PA, SC,TX, and WA .
Timeline
- Recall initiated
- 2007-02-07
- Posted by FDA
- 2007-03-31
- Terminated
- 2007-11-15
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #50493. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.