RadPRO — Class II medical device recall Z-0460-2019
Terminated recall by Virtual Imaging, Inc., reported 2018-11-21, distributed nationwide. There is a potential for the RadPRO Mobile 40kW Digital X-Ray System Model SM-40HF-B-D-C to separate from the
| Recall number | Z-0460-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Virtual Imaging, Inc., Deerfield Beach, FL, United States |
| Recall initiated | 2018-11-02 |
| Classified | 2018-11-13 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2020-08-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, IT |
| Quantity | 253 units |
| Model numbers | SM-40HF-B-D-C |
Product
RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric subjects. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
Reason for recall
There is a potential for the RadPRO Mobile 40kW Digital X-Ray System Model SM-40HF-B-D-C to separate from the Tube Head Mount and potentially fall off the system.
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-0460-2019. 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.