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Terminated

DeGotzen XRay unit XGenus Dental X-ray unit.

FDA Recall Z-1020-2013 · Posted 2013-04-17

Recalling FirmDeGotzen
Recall StatusTerminated
Product CodeEAP
Date Initiated2012-09-26
Date Terminated2018-05-07
Product Quantity159 units

Reason for Recall

It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification

Firm Action

DeGotzen will add new labeling or change existing labeling to correct for the 5 mentioned deficiencies. This correction of the noncompliant products must be made at no cost to the customers. For further questions please call 800-289-6367 ext. 390.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US (nationwide)

Official Source

View FDA Recall →

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

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