Recall Z-0460-2019
Virtual Imaging, Inc. · initiated November 2, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: G61814 G60652 G60606 G62565 G62687 G62500 G62883 G62690 G62750 G62502 G62867 G62891 G62626 G63322 G63328 G62900 G62564 G62037 G62480 G36042 G36206 G36287 G36526 G36643 G37129 G37633 G37641 G38635 G38652 G38657 G39465 G39533 G39544 G39551 G39589 G39639 G39650 G39657 G39782 G39791 G39800 G39801 G39808 G39809 G39818 G40004 G40016 G40024 G40116 G40124 G40126 G40133 G40199 G40203 G40208 G40216 G40226 G41058 G41066 G41083 G41098 G41100 G41104 G41108 G41109 G41114 G41119 G41192 G41213 G41218 G41244 G41245 G60058 G60061 G60062 G60063 G60064 G60065 G60066 G60067 G60069 G60070 G60400 G60406 G60407 G60415 G60418 G60429 G60430 G60431 G60432 G60435 G60520 G60576 G60577 G60582 G60597 G60635 G61307 G61311 G61333 G61337 G61356 G61367 G61368 G61698 G61706 G61711 G61715 G61716 G61720 G61725 G61786 G61795 G61804 G61812 G61814 G61818 G61867 G61872 G61872 G61873 G61880 G62011 G62012 G62015 G62029 G62030 G62053 G62062 G62066 G62511 G62558 G62566 G62567 G62626 G62747 G62762 G62804 G62815 G62816 G62821 G62828 G62863 G62892 G62938 G62943 G63212 G63223 G63224 G63232 G63318 G63328 G63335 G63392 G63418 G63477 G63488 G63489 G63494 G63495 G63501 G63507 G64179 G64188 G64189 G64196 G64198 G64205 G64206 G64271…
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.
FDA-determined cause: Component change control
Action taken
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.
Details
- Recall number
- Z-0460-2019
- Initiated
- November 2, 2018
- Terminated
- August 19, 2020
- Product code
- MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Quantity
- 253 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of, Canada, Italy
- Recalling firm
- Virtual Imaging, Inc., Deerfield Beach, FL