AEROSET System Software version 1.00ER005 Catalog Number 2-89996-01 and 1.00ER005.2 Catalog Number 2-89996-02, distribut
FDA device recall Z-0721-03 · posted 2003-04-15 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- The autoprint feature allows the switch of patient IDs in remote cases.
- Action taken
- The firm sent a Device Correction letter to all consignees on 12/12/2002, requesting that the users make adjustments to their systems, and retain the letter in their user manual. The letter included a customer reply form. The software will be corrected with the release of the next version.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 640
- Distribution
- Nationwide and to the following foreign countries: Mexico, Columbia, Dominican Republic, Hong Kong, Guatemala, Argentina, Canada, Australia, Venezuela, Brazil, Germany, New Zeland
- Date initiated
- 2002-12-12
- Date posted
- 2003-04-15
- Date terminated
- 2004-10-28
- Location
- Irving, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.