BVS 5000t Bi-Ventricular Support System Transport/Backup Console Catalog Number: 0050-000
FDA device recall Z-1222-03 · posted 2003-09-11 · Terminated
Recall details
- Recalling firm
- Abiomed, Inc.
- Reason for recall
- Bi-Ventricular support system may switch to battery when primary voltage (AC) is available
- Action taken
- Abiomed notified customers by letter on 8/19/03 advising users of the problem and requesting that the unit not be used until a field service representative corrected the device.
- Root cause
- Other
- Status
- Terminated
- Product code
- DSQ
- Quantity affected
- 36
- Distribution
- Nationwide. CA, DE, IL, IN, KY, FL, LA, MD, ND, NJ, NY, OR, WI, TX
- Date initiated
- 2003-08-19
- Date posted
- 2003-09-11
- Date terminated
- 2003-10-15
- Location
- Danvers, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.