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Terminated

AxSYM System, Lift Mechanisms: List Numbers 7A83-01, 7A83-95, 7A83-98, and 7A83-03

FDA Recall Z-0421-03 · Posted 2003-01-11

Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2002-12-18
Date Terminated2004-04-07
Product Quantity18,832 units

Reason for Recall

Gas Springs supporting processing center cover lose pressure after repeated usage causing the cover to unexpectedly close.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K974651ABBOTT AXSYM SYSTEMAbbott Laboratories · 1998-02-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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