Recall Z-0460-2019— Virtual Imaging, Inc.
Class II · Terminated
Class II FDA medical device recall by Virtual Imaging, Inc., initiated 2018-11-02, terminated 2020-08-19. It names one FDA 510(k) clearance: K101517. 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: 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..
- Recalling firm
- Virtual Imaging, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-02
- Terminated
- 2020-08-19
- Firm location
- Deerfield Beach, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.