iLab Ultrasound Imaging System, Models 120INS and 240INS, manufactured by Boston Scientific Corporation, Fremont, CA 945
FDA device recall Z-1693-2008 · posted 2008-09-23 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Improperly terminated wires on a component of the iLab Acquisition processor power supply could cause the processor to lock-up or stop, and prolong the patients procedure.
- Action taken
- On April 4 and 10, 2008, customer notifcations were sent to consignees. Field corrections are estimated to begin on April 25, 2008.
- Root cause
- Process control
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 120 units
- Distribution
- Product was distributed to a total of 81 consignees in the USA, Hong Kong, Great Britain, Austria and France.
- Date initiated
- 2000-04-11
- Date posted
- 2008-09-23
- Date terminated
- 2009-04-06
- 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 |
|---|---|---|
| ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3 (K072517) | Boston Scientific Corp | 2007-09-26 |