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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMay 15, 2003
Date PostedDecember 19, 2003
Recall Status1 Terminated 3 on November 01, 2004
Recall NumberZ-0729-03
Recall Event ID 27108
510(K)NumberK022737 
Product Classification System, X-Ray, Stationary - Product Code KPR
ProductHCMI operator control panels for chiropractic x-ray systems, Model #HF300, HF600, HF3SE, and HF3SEE.
Code Information 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.
FEI Number 1929884
Recalling Firm/
Manufacturer		 Health Care Manufacturing Inc
2146 East Pythian
Springfield MO 65802
For Additional Information ContactMarty A. Lewis
417-864-6511
Manufacturer Reason
for Recall		Required labeling (certification and manufacturer's label) was missing from the Operator Control Panels
FDA Determined
Cause 2		Other
ActionThe 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 Commerce476 units
DistributionDistribution was made to dealers located nationwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KPR
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