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U.S. Department of Health and Human Services

Class 2 Device Recall RadPRO Mobile 40kW Digital XRay System

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  Class 2 Device Recall RadPRO Mobile 40kW Digital XRay System see related information
Date Initiated by Firm November 02, 2018
Create Date November 14, 2018
Recall Status1 Terminated 3 on August 19, 2020
Recall Number Z-0460-2019
Recall Event ID 81444
510(K)Number K101517  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
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
Code Information 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 G64274 G64500 G64505 G64512 G64520 G64582 G64597 G64604 G64607 G64713 G64789 G64793 G64797 G64798 G64812 G64813 G64819 G64842 G64849 G64854 G64855 G64883 G64885 G64891 G64891 G64893 G64941 G64945 G65036 G65043 G65166 G65168 G65172 G65174 G65175 G65260 G65266 G65275 G65281 G65284 G65286 G65289 G65382 G65384 G65393 G62493 G65395 G65400 G65402 G62684 G65408 G65414 G62682 G65418 G65554 G65558 G65568 G65570 G65588 G65682 G62815 G65744 G41267 G66862 G66892 G63333 G63409 G66907 G67230 G67232 G67250 G68470 G70521 G70524 G70742 G70744 G70748 G70752 G70755 G70913 G70919 G70922 
Recalling Firm/
Manufacturer		 Virtual Imaging, Inc.
720 S Powerline Rd Ste E
Deerfield Beach FL 33442-8156
For Additional Information Contact
561-893-8400
Manufacturer 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 2		 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 in Commerce 253 units
Distribution Worldwide Distribution - US Nationwide and the countries of, Canada, Italy
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = SEDECAL S.A.
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