FDA Medical Device Recalls (openFDA)
Abbott Laboratories, Inc: AEROSET System Software version 1.00ER005 Catalog Number 2-89996-01 and 1.00ER005.2 Catalog Number 2-89996-02, distributed by Abbott Laboratories
- Recall number
- Z-0721-03
- Recalling firm
- Abbott Laboratories, Inc
- Product
- AEROSET System Software version 1.00ER005 Catalog Number 2-89996-01 and 1.00ER005.2 Catalog Number 2-89996-02, distributed by Abbott Laboratories
- Status
- Terminated
- Initiated
- 2002-12-12
- Posted
- 2003-04-15
- Terminated
- 2004-10-28
- Reason
- The autoprint feature allows the switch of patient IDs in remote cases.
- Root cause
- Other
- Action
- 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.
- Quantity
- 640
- Distribution
- Nationwide and to the following foreign countries: Mexico, Columbia, Dominican Republic, Hong Kong, Guatemala, Argentina, Canada, Australia, Venezuela, Brazil, Germany, New Zeland
- Lot, serial or model codes
- Version 1.00ER005 Catalog Number 2-89996-01 and Version 1.00ER005.2 Catalog Number 2-89996-02 AEROSET System software is not controlled by Control or Lot numbers.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1628664
- Firm city
- Irving
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28