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Terminated

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

FDA Recall Z-0460-2019 · Posted None

Recalling FirmVirtual Imaging, Inc.
Recall StatusTerminated
Product CodeMQB
Date Initiated2018-11-02
Date Terminated2020-08-19
Product Quantity253 units

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.

Firm Action

The firm initiated the field correction by issuing a field safety notice on 11/03/2018. The letter identified the affected product, problem and action to be taken.

Root Cause

Component change control

Distribution Pattern

Worldwide Distribution - US Nationwide and the countries of, Canada, Italy

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101517SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAYSedecal., Sa. · 2011-08-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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