Recall Z-0729-03 ยท KPR System, X-Ray, Stationary
Health Care Manufacturing Inc
HCMI operator control panels for chiropractic x-ray systems, Model #HF300, HF600, HF3SE, and HF3SEE.
| Date | Dec 19, 2003 (initiated May 15, 2003) |
| Status | Terminated |
| Reason | Required labeling (certification and manufacturer's label) was missing from the Operator Control Panels |
| 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 | 476 units |
| Distribution | Distribution was made to dealers located nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022737 | HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC Health Care Mfg., Inc., Oct 22, 2002 |