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Terminated

Gendex Dental Systems, Gendex eXpert DC Intraoral X-Ray System; a dental x-ray system; Model 110-0205G1, catalog number EXPERTDC75NA

FDA Recall Z-1248-2011 · Posted 2011-02-15

Recalling FirmGendex Dental Systems
Recall StatusTerminated
Product CodeEHD
Date Initiated2010-12-17
Date Terminated2011-02-15
Product Quantity5 units

Reason for Recall

The intraoral x-ray systems were installed improperly with incorrect screws which allow the unit to pull away from the wall when the arm is fully extended. This condition may harm the patient.

Firm Action

Gendex sent a Urgent Medical Device Field Correction letter dated December 17, 2010 to the consignee, informing them that the x-ray units were installed with improper sized lag bolts and requesting that they contact Gendex Customer Service at 1-800-323-8029 to complete the field correction.

Root Cause

Component design/selection

Distribution Pattern

California

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992610GENDEX 765DC, MODEL 110-0154Dentsply Intl. · 1999-09-07

Official Source

View FDA Recall →

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

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