AxSYM System, Lift Mechanisms: List Numbers 7A83-01, 7A83-95, 7A83-98, and 7A83-03
FDA device recall Z-0421-03 · posted 2003-01-11 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- Gas Springs supporting processing center cover lose pressure after repeated usage causing the cover to unexpectedly close.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 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,
- Date initiated
- 2002-12-18
- Date posted
- 2003-01-11
- Date terminated
- 2004-04-07
- Location
- Irving, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT AXSYM SYSTEM (K974651) | Abbott Laboratories | 1998-02-12 |