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Terminated

Radionics Head and Neck Localilizer (HNL), Version B

FDA Recall Z-1020-04 · Posted 2004-07-20

Recalling FirmRadionics, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2004-05-25
Date Terminated2005-02-28
Product Quantity4

Reason for Recall

Software may provide inaccurate coordinates and cause mistreatment

Firm Action

Radionics notified users by telephone and follow-up letters dated 5/25/04 via facsmile. Users are requested not to use the system. A corrected software will be issued.

Root Cause

Other

Distribution Pattern

Canada, Germany, Greece

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991237XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNLRadionics, Inc. · 1999-08-30

Official Source

View FDA Recall →

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

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