Z-0729-03

HCMI operator control panels for chiropractic x-ray systems, Model #HF300, HF600, HF3SE, and HF3SEE

Name: Z-0729-03 HCMI operator control panels for chiropractic x-ray systems, Model #HF300, HF600, HF3SE, and HF3SEE
Creator: Health Care Manufacturing Inc
Published: 2003-05-15
License: https://open.fda.gov/license/

Health Care Manufacturing Inc / initiated 2003-05-15 / Terminated / root cause: labeling and UDI

FDA source

Health Care Manufacturing Inc began a recall of HCMI operator control panels for chiropractic x-ray systems, Model #HF300, HF600, HF3SE, and HF3SEE on 2003-05-15. The reason FDA records is "Required labeling (certification and manufacturer's label) was missing from the Operator Control Panels". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0729-03
Status: Terminated
Initiated: 2003-05-15
Posted: 2003-12-19
Terminated: 2004-11-01
Recalling firm: Health Care Manufacturing Inc
Product: HCMI operator control panels for chiropractic x-ray systems, Model #HF300, HF600, HF3SE, and HF3SEE.
Product code: KPR System, X-Ray, Stationary
Reason for recall: Required labeling (certification and manufacturer's label) was missing from the Operator Control Panels
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm initiated recall with telephone calls approximately 5/15/03 requesting the dealers to provide customer names so they could send corrective labels directly to the users.
Quantity in commerce: 476 units
Distribution: Distribution was made to dealers located nationwide.
Product codes and lots: Serial numbers 108, 111, 140, 153, 160, 180, 214, 217, 238, 242, 246, 247, 251 thru 254, 256 thru 267, 269 thru 272, 275, 276, 279, 280, 283, 284, 287, 288, 289, 302 thru 318, 321, 322, 323, 330 thru 334, 352, and 1001 thru 1407.

Product code KPR

K022737Class IIHcmi X-Ray High Requency Chiropractic RadiographicHealth Care Mfg., Inc. / cleared 2002-10-22

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)