Z-1020-04

Radionics Head and Neck Localilizer (HNL), Version B

Name: Z-1020-04 Radionics Head and Neck Localilizer (HNL), Version B
Creator: Radionics, Inc.
Published: 2004-05-25
License: https://open.fda.gov/license/

Radionics, Inc. / initiated 2004-05-25 / Terminated / root cause: software

FDA source

Radionics, Inc. began a recall of Radionics Head and Neck Localilizer (HNL), Version B on 2004-05-25. The reason FDA records is "Software may provide inaccurate coordinates and cause mistreatment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1020-04
Status: Terminated
Initiated: 2004-05-25
Posted: 2004-07-20
Terminated: 2005-02-28
Recalling firm: Radionics, Inc.
Product: Radionics Head and Neck Localilizer (HNL), Version B
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Software may provide inaccurate coordinates and cause mistreatment
Root cause tag: software
FDA root cause: Other
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.
Quantity in commerce: 4
Distribution: Canada, Germany, Greece
Product codes and lots: Serial Numbers: 032610023, 0326100023, 32690010, 041200023

Product code MUJ

K991237Class IIXplan-2 with Head and Neck Localizer, Model HnlRadionics, Inc. / cleared 1999-08-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)