eXpertDC intraoral x-ray — Class II medical device recall Z-0009-2015
Terminated recall by Gendex Corp, reported 2014-10-08, distributed nationwide. Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke dur
| Recall number | Z-0009-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gendex Corp, Hatfield, PA, United States |
| Recall initiated | 2014-08-12 |
| Classified | 2014-10-02 |
| Reported by FDA | 2014-10-08 |
| Terminated | 2017-03-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, RU, SG, TH, TW |
| Quantity | 651 |
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, 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0009-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.