Z-0556-2021Class II

MH-200S, system with Ceiling Suspended C-arm Support -

Name: Z-0556-2021 MH-200S, system with Ceiling Suspended C-arm Support -
Creator: Shimadzu Medical Systems
Published: 2020-11-18
License: https://open.fda.gov/license/

Shimadzu Medical Systems / initiated 2020-11-18 / Open, Classified / root cause: software

FDA source

Shimadzu Medical Systems began a recall of MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal... on 2020-11-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0556-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-11-18
Posted: 2020-12-10
Recalling firm: Shimadzu Medical Systems
Product: MH-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.
Product code: IZI System, X-Ray, Angiographic
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.
Root cause tag: software
FDA root cause: Software design
Action: On 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 [email protected] D. Shimadzu
Quantity in commerce: 22 units
Distribution: US Nationwide distribution including in the states of KY, CA, MI, OH, CT, MI, NY, SC, NC,IN, IL, TN, LA, CT, MT.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0556-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0554-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-16	2020-12-10
Z-0555-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-16	2020-12-10
Z-0556-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-16	2020-12-10

Product code IZI

K943545Class IICeiling Suspended C-Arm Support Mh-100Shimadzu Medical Systems / cleared 1995-02-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)