HCMI operator control panels for chiropractic x-ray systems, Model #HF300, HF600, HF3SE, and HF3SEE.
FDA device recall Z-0729-03 · posted 2003-12-19 · Terminated
Recall details
- Recalling firm
- Health Care Manufacturing Inc
- Reason for recall
- Required labeling (certification and manufacturer's label) was missing from the Operator Control Panels
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 476 units
- Distribution
- Distribution was made to dealers located nationwide.
- Date initiated
- 2003-05-15
- Date posted
- 2003-12-19
- Date terminated
- 2004-11-01
- Location
- Springfield, MO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC (K022737) | Health Care Mfg., Inc. | 2002-10-22 |