Mobile wDR motorized portable diagnostic X-ray systems — Class II medical device recall Z-1084-2016
Terminated recall by Sedecal S.A., reported 2016-03-16, distributed nationwide. This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system.
| Recall number | Z-1084-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sedecal S.A., Algete, N/A, Spain |
| Recall initiated | 2016-01-18 |
| Classified | 2016-03-08 |
| Reported by FDA | 2016-03-16 |
| Terminated | 2018-02-07 |
| Distributed | Nationwide (US) |
| Quantity | 349 systems |
| Serial numbers | 12000166, 13000046, 13000047, 13000048, 13000049, 13000053, 13000054, 13000055, 13000056, 13000057, 13000058, 13000060, 13000067, 13000070, 13000071, 13000075, 13000076, 13000077, 13000078, 13000079, 13000085, 13000092, 13000093, 13000094, 13000109 and 327 more |
Product
Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
Reason for recall
This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system. Reason for Recall: Along with the previously noted encoder and gauges problems and corresponding fixes, we have observed that static electricity can also elicit the unwanted behavior.
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-1084-2016. 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.