FDA Medical Device Recalls (openFDA)
Radionics, Inc.: Radionics Head and Neck Localilizer (HNL), Version B
- Recall number
- Z-1020-04
- Recalling firm
- Radionics, Inc.
- Product
- Radionics Head and Neck Localilizer (HNL), Version B
- Status
- Terminated
- Initiated
- 2004-05-25
- Posted
- 2004-07-20
- Terminated
- 2005-02-28
- Reason
- Software may provide inaccurate coordinates and cause mistreatment
- 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
- 4
- Distribution
- Canada, Germany, Greece
- Lot, serial or model codes
- Serial Numbers: 032610023, 0326100023, 32690010, 041200023
- 510(k) numbers
- ["K991237"]
- PMA numbers
- not on file
- Product code
- MUJ
- Firm FEI
- 1000120652
- Firm city
- Burlington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28