Recall Z-0556-2021
Shimadzu Medical Systems · initiated November 18, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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
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: Software design
Action taken
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 drodriguez@shimadzu-usa.com D. Shimadzu
Details
- Recall number
- Z-0556-2021
- Initiated
- November 18, 2020
- Product code
- IZI – System, X-Ray, Angiographic
- Quantity
- 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.
- Recalling firm
- Shimadzu Medical Systems, Torrance, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0554-2021 Class II | Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm…The firm has identified a problem with the control software for the celling arm of the X-Ray System . This… | 11/18/2020Open, Classified |
| Z-0555-2021 Class II | Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support…The firm has identified a problem with the control software for the celling arm of the X-Ray System . This… | 11/18/2020Open, Classified |