FDA Medical Device Recalls (openFDA)
Abbott Laboratories, Inc: AxSYM System, Lift Mechanisms: List Numbers 7A83-01, 7A83-95, 7A83-98, and 7A83-03
- Recall number
- Z-0421-03
- Recalling firm
- Abbott Laboratories, Inc
- Product
- AxSYM System, Lift Mechanisms: List Numbers 7A83-01, 7A83-95, 7A83-98, and 7A83-03
- Status
- Terminated
- Initiated
- 2002-12-18
- Posted
- 2003-01-11
- Terminated
- 2004-04-07
- Reason
- Gas Springs supporting processing center cover lose pressure after repeated usage causing the cover to unexpectedly close.
- Root cause
- Other
- Action
- Abbott Laboratories sent a December 18, 2002 letter to all consignees informing consignees of their plans to install a locking mechanism on all AxSYM Systems. The installations will be performed by Abbott Representatives. A customer reply form was included in the device correction letter.
- Quantity
- 18,832 units
- Distribution
- Nationwide and to the following foreign countries: Mexico, Guatemala, Venezuela, Columbia, Ecuador, Peru, Chile, Uruguay, Argentina, Brazil, Dominican Republic, El Salvador, Canada, Germany, Ireland, England, Belgium, France, Austria, Italy, Spain, Russia, Japan, Singapore, Hong Kong, Taiwan, Thailand, Malaysia, Korea, Australia, New Zeland, Honduras, Costa Rica, Trinidad, Bahamas, Northern Antilles, Bermuda, Panama, West Indies, Paraguay, Norway, Kingstow, VC
- Lot, serial or model codes
- List Numbers: 7A83-01, 7A83-95, 7A83-98, and 7A83-03
- 510(k) numbers
- ["K974651"]
- 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