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U.S. Department of Health and Human Services

Class 2 Device Recall MH200S

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 Class 2 Device Recall MH200Ssee related information
Date Initiated by FirmNovember 18, 2020
Create DateDecember 10, 2020
Recall Status1 Open3, Classified
Recall NumberZ-0556-2021
Recall Event ID 86846
510(K)NumberK943545 
Product Classification System, x-ray, angiographic - Product Code IZI
ProductMH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
Code Information Affected Serial Numbers: 0161K35901, 0161K46901, 0161K58202, 0161K56001, 0161K55702, 0161K55301, 0161K55202, 0161K47102, 0161K46802, 0161K46301, 0161K36501, 0161K36301, 0161K35702, 0161K36202, 40AAE701B001, 0161K49301, 0161K48601, 0161K48501, 0161K36402, 0161K35602, 0161K35202, 0161K56502 
Recalling Firm/
Manufacturer		 Shimadzu Medical Systems
20101 S Vermont Ave
Torrance CA 90502-1328
For Additional Information ContactMr. John Goossens
310-217-8855 Ext. 117
Manufacturer Reason
for Recall		The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
FDA Determined
Cause 2		Software design
ActionOn 11/18/2020 Shimadzu sent an "Urgent Medical Device Recall Notice" to all affected consignees. In addition to informing consignees about the recall the firm provided the following information. 1. Shimadzu has released a mandatory Service Bulletin on applicable products for the update of the positioner software. The update of the software and the testing of the positioner movement should be performed by your Authorized Shimadzu Service provider. 2. Your authorized Distributor has acknowledged receipt the Service Bulletin (XR-202026) and the recall Customer Letter. They have been instructed to provide you a copy of this letter so that you may understand the scope of the recall. Necessary software for this recall and instruction to complete have been sent to your Distributer and they should be scheduling time to perform the corrective actions. 3. Once the corrective work has been completed your Distributor will report to Shimadzu that the work has been completed so that we may track and inform the appropriate Regulatory Agencies of its completion. Actions to be taken by customer: A. Please check the list of systems affected by this recall. If your site is on the applicable list, please pay attention to the following points until the corrective work has been completed. . (1) This event does not occur in any position other than the Left or Right diagonal position, so please avoid using this product in diagonal positions. (2) When using the product in the Left or Right diagonal position, please use the direct memory function and encourage C-arm operation without using the lever. (3) If the C-arm starts to operate unintentionally, press the red "Stop Switch" button immediately. B. If you feel there is a problem with the c-arm movement, please discontinue use of the system and contact your local service provider. C. Please complete the Medical device Recall Return Response form and submit to drodriguez@shimadzu-usa.com D. Shimadzu
Quantity in Commerce22 units
DistributionUS Nationwide distribution including in the states of KY, CA, MI, OH, CT, MI, NY, SC, NC,IN, IL, TN, LA, CT, MT.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IZI
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