Class 2 Device Recall MUX100H. Mobile xray system.

• Date Initiated by Firm: October 28, 2011
• Date Posted: November 08, 2012
• Recall Status: Terminated on July 26, 2016
• Recall Number: Z-0262-2013
• Recall Event ID: 62271
• 510(K)Number: K001517
• Product Classification: System, x-ray, mobile - Product Code IZL
• Product: 0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classification Name: Mobile x-ray system. Device Model#MUX-100H. Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
• Code Information: S/N of X-ray tube: 63049 63048 63074 63081 63082 63077 63350 63349 63629 63647 63909 62729 64214 66033 66032 70070 70065 70364 66327 66331 70058 66325 70955 71241 70920 71848 72472 72462 73056 73058 73341 73675 74577 74563 74565 74557 74558 74846 74845 75455 75452 75457 75728 75737 75736 76059 76057 76060 76054 76062 76360 76366 76612 76636 76336 76916 76655 76647 76938 76940 2XY080646 2XY0081249 2XY0081245 2XY0081543 2XY0081858 2XY0081849 2XY0081855 2XY0081856 2XY0081865 2XY0081862 2XY0082746 2XY0082764 2XY0083055 2XY0083052 2XY0083064 2XY0083051 2XY0083053 2XY0083038 2XY0083063 2XY0083063 2XY0083065 2XY0083343 2XY0083340 2XY0083349 2XY0083354 2XY0083360 2XY0083355 2XY0083646 2XY0083359 2XY0083652 2XY0083670 2XY0083674 2XY0083655 2XY0083673 2XY0083675 2XY0083665 2XY0083645 2XY0083643 2XY0083629 2XY0074577 2XY0083638 2XY0083943 2XY0083671 2XY0083933 2XY0083930 2XY0083925 2XY0084532 2XY0084558 2XY0084546 2XY0084553 2XY0084538 2XY0084846 2XY0084565 2XY0084845 2XY0085124 2XY0085137 2XY0085127 2XY0084578 2XY0085140 2XY0085143 2XY0085141 2XY0086351 2XY0084860 2XY0084856 2XY0084851 2XY0084859 2XY0086344 2XY0084852 2XY0086365 2XY0086364 2XY0086373 2XY0086368 2XY0086665 2XY0086674 2XY0087077 2XY0087371 2XY0087044 2XY0087036 2XY0087041
• Recalling Firm/ Manufacturer: Shimadzu Medical Systems; 20101 S Vermont Ave; Torrance CA 90502-1328
• For Additional Information Contact: 310-217-8855 Ext. 139
• Manufacturer Reason for Recall: Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Shimadzu sent an Urgent Voluntary Medical Device Recall - Field Safety Notice letters dated September 19, 2012 to all the affected customers. The letter identifed the description of non-compliance, how to identify the affected products, corrective action plan by Shimadzu and actions to be taken customers. Customers were instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at Shimadzu Medical Systems National Technical Support (800) 228-1429.
• Quantity in Commerce: 288 units
• Distribution: US Nationwide Distribution
• 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 = IZL