Gendex eXpertDC Intraoral X-Ray Recall for Spring Link Failures
Gendex Corp is recalling 651 eXpertDC intraoral x-ray units worldwide because spring link components in the articulated arm assembly broke during normal assembly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves mechanical component failure during the assembly process prior to full load installation, with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Gendex Corp is recalling 651 units of the eXpertDC intraoral x-ray system. The affected models include various reach configurations (55, 65, and 75 inches) for North America, China, and World Wide markets, as well as specific OEM arm assemblies and articulated arm and tubehead assemblies.
The recall was initiated due to two reported failures of the spring link components within the articulated arm assembly. These spring links broke during the normal assembly process for the articulated arm during the first cycle of the arm. This occurred prior to the 14lb tube head (full load) being installed onto the assembled articulated arm.
The affected products were distributed worldwide, including the United States, Europe, Canada, Australia, China, Russia, Taiwan, Singapore, and Thailand. Users of these devices should contact Gendex Corp for further instructions regarding the recall.
The recalled product
- Product
- 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…
- Manufacturer
- Gendex Corp
- Category
- Medical Device — Dental Imaging
- Hazard
- Affected units
- 651
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- Models: eXpert DC
- NA
- 75 Inch reach
- eXpert DC
- 65 Inch reach
- CN
- 55 Inch reach
- WW
- OEM Arm Assembly w/o cables
- Assy
- Articulated Arm & Tubehead
- eDC
- and Assy
- Articulated Arm & Tubehead
- 765DC
Distribution
Distributed nationwide across the United States.
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