Drug recall
RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take…
FDA recall event 81444 · Class II · Virtual Imaging, Inc.
Key facts
| Event ID | 81444 |
|---|---|
| Recall numbers | Z-0460-2019 |
| Recalling firm | Virtual Imaging, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Nov 2, 2018 |
| Report date | Nov 21, 2018 |
| Termination date | Aug 19, 2020 |
| City | Deerfield Beach |
| State | FL |
| Country | United States |
| FEI number | 1000649926 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: