FDA Device Recall Z-0009-2015: Gendex Corp

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0009-2015.

Recall Res Number

Z-0009-2015

Recalling Firm / Manufacturer

Gendex Corp

FEI Number

3009212242

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2014-08-12

Date Posted

2014-10-02

Date Terminated

2017-03-24

Product Code

EHD

Event Number

69064

Product Quantity

651

Product Description eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray

Reason for Recall Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke during normal assembly process for the articulated arm during first cycle of the arm, prior to the 14lb tube head (full load) being installed onto the assembled articulated arm.

Action Details Gendex sent a Recall Notification Letter, dated August 12, 2014 and a second Communication Notification letter on September 22, 2014 to all affected customers. The letter identified the affected product, problem, and actions to be taken. For questions contact Gendex Customer Service at 1-800-323-8029.

Distribution Pattern Worldwide Distribution - US Nationwide and the countries of Europe, Canada, Australia, China, Russia, Taiwan, Singapore, and Thailand.

Code Information / Serial Numbers Models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC; with multiple part numbers and serial numbers: see distribution list for these details.

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Medical Device Recall: Z-0009-2015

Recall Parameters & Description

Related Establishments / Registrations

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