FDAFDA · Food and drugs·Recall number Z-0009-2015
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
Published October 8, 2014 · Recall initiated: August 12, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Gendex Corp
- Distributor
- Worldwide Distribution - US Nationwide and the countries of Europe, Canada, Australia, China, Russia, Taiwan, Singapore, and Thailand.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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