iReview" Software (Accessory To) iLab Ultrasound Imaging System, Model Number: H74900018010, Catalog Number: 1801; Produ
FDA device recall Z-2006-2008 · posted 2008-09-17 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- The firm initiated a recall of a specific iReview" Software, Ver 1.0 Kit, which was released for distribution in a non-validated format.
- Action taken
- Customer notifications sent on May 2, 2008 indicating the need for field correction and included a replacement version of the software kit. For customer assistance, contact Boston Scientific at 1-508-652-5594.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 10 kits
- Distribution
- Product was distributed in FL, MI, CA, AZ and SC
- Date initiated
- 2008-05-02
- Date posted
- 2008-09-17
- Date terminated
- 2009-06-01
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0 (K063493) | Boston Scientific Corp | 2006-12-21 |