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FDA Medical Device Recalls (openFDA)

Health Care Manufacturing Inc: HCMI operator control panels for chiropractic x-ray systems, Model #HF300, HF600, HF3SE, and HF3SEE.

Recall number
Z-0729-03
Recalling firm
Health Care Manufacturing Inc
Product
HCMI operator control panels for chiropractic x-ray systems, Model #HF300, HF600, HF3SE, and HF3SEE.
Status
Terminated
Initiated
2003-05-15
Posted
2003-12-19
Terminated
2004-11-01
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.
Lot, serial or model codes
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.
510(k) numbers
["K022737"]
PMA numbers
not on file
Product code
KPR
Firm FEI
1929884
Firm city
Springfield
Firm state
MO
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

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