Recall Z-0460-2019 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Virtual Imaging, Inc.
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
| Date | Nov 2, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component change control |
| 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. |
| Quantity | 253 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of, Canada, Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101517 | SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY Sedecal., Sa., Aug 5, 2011 |