Recall Z-0555-2021 ยท OWB Interventional Fluoroscopic X-Ray System
Shimadzu Medical Systems
Trinias, Digital Angiography System containing a MH-200, 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.
| Date | Nov 18, 2020 |
| Status | Open, Classified |
| Reason | 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 | 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 instructe |
| Quantity | 23 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123508 | TRINIAS Shimadzu Corporation, Feb 26, 2014 |