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Terminated

Gendex eXpert DC Intraoral Dental X-Ray System Device is to be used as an extra-oral source of X-Rays in Dental Radiography

FDA Recall Z-1358-2012 · Posted 2012-04-02

Recalling FirmGendex Dental Systems
Recall StatusTerminated
Product CodeEHD
Date Initiated2011-12-29
Date Terminated2012-06-01
Product Quantity52

Reason for Recall

Improper hardware was used during installation of the eXpert DC Intraoral X-Ray system units causing drifting of the tubehead assembly.

Firm Action

Gendex Dental Systems sent a Urgent Medical Device Correction letter dated December 29, 2011, to both affected customers. The Customers were provided background information and details on how the nonconforming installations of the devices would be corrected. Gendex Dental Systems apologizes for any inconvenience caused by this issue, and request your corporation as we correct this problem. The customers were instructed to complete and return the Acknowledgement Form upon receipt of the recall notification letter and fax to (215) 997-5665. For further questions please call (215) 954-0365.

Root Cause

Nonconforming Material/Component

Distribution Pattern

USA including the states of Iowa and Illinois.

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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