Boston Scientific SpyGlass Camera Ref Number: 4610 UPN M00546100
FDA device recall Z-0699-2007 · posted 2007-03-31 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- A teal "bloom"/ glare on the subject image during high light conditions.
- 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
- 12 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
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Related 510(k) clearances
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|---|---|---|
| VISTA SINGLE CHIP VIDEO CAMERA (K971373) | Vista Medical Technologies, Inc. | 1997-05-20 |