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Terminated

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

FDA Recall Z-0729-03 · Posted 2003-12-19

Recalling FirmHealth Care Manufacturing Inc
Recall StatusTerminated
Product CodeKPR
Date Initiated2003-05-15
Date Terminated2004-11-01
Product Quantity476 units

Reason for Recall

Required labeling (certification and manufacturer's label) was missing from the Operator Control Panels

Firm 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.

Root Cause

Other

Distribution Pattern

Distribution was made to dealers located nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022737HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHICHealth Care Mfg., Inc. · 2002-10-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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