Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 21, 2018
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
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.
Virtual Imaging, Inc. recalled RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: I… - a moderate-severity action.
RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: I… was recalled by Virtual Imaging, Inc. in November 21, 2018. Reason: There is a potential for the RadPRO Mobile 40kW Digital X-Ray System Model SM-40HF-B-D-C to separate from the…. Check the official notice for the remedy. Verify recall #Z-0460-2019 with the FDA Devices before acting.
The recall
Virtual Imaging, Inc. issued this moderate-severity FDA Devices recall-There is a potential for the RadPRO Mobile 40kW Digital X-Ray System Model SM-40HF-B-D-C to separate from the….
- Moderate
- severity level
- 253 units
- affected scope
- Class II
- classification
- November 21, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0460-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0460-2019) was formally reported on November 21, 2018, with the manufacturer initiating the action on November 2, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Virtual Imaging, Inc. is listed as the recalling firm, operating out of Deerfield Beach, FL. Federal records list the affected scope as 253 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide and the countries of, Canada, Italy. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
253 units
Related Recalls
6
6 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0460-2019 |
| Date reported | November 21, 2018 |
| Date initiated | November 2, 2018 |
| Recalling firm | Virtual Imaging, Inc. |
| Firm location | Deerfield Beach, FL |
| Affected scope | 253 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of, Canada, Italy |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0460-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Virtual Imaging, Inc.. Units affected: 253 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 21, 2018. Severity: Moderate. Recall number: Z-0460-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide and the countries of, Canada, Italy.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0460-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 21, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.