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Terminated

Neuro Adapter 2 used with the Berchtold B-810 Surgical Table or Getinge USA Fortis Surgical Table Catalog No: MDTNA2

FDA Recall Z-1327-04 · Posted 2004-08-07

Recalling FirmAllen Medical Systems
Recall StatusTerminated
Product CodeFQO
Date Initiated2004-07-12
Date Terminated2005-05-05
Product Quantity29 units

Reason for Recall

Neuro adapter may fail to engage and adequately clamp to the surgical table, resulting in movement

Firm Action

Allen Medical notified the two distributors by telephone on 7/12/04 and 7/16/04. A customer notifcation letter issued requesting return of the device for correction.

Root Cause

Other

Distribution Pattern

SC

Official Source

View FDA Recall →

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

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