Recall Z-2294-2026 ยท OWB Interventional Fluoroscopic X-Ray System
Shimadzu Medical Systems
Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST alexa:UD150G-40 / D150GC-40; Digital Radiography System RADspeed Pro: UD150B-40 / UD150V-40 / UD150L-40 / UD150L-40E/D150BC-40 / D150VC-40 / D150LC-40 / D150LC-40E/D150BC-41 / D150VC-41 / D150LC-41; Digital Radiography System RADspeed safir
| Date | Jun 2, 2026 (initiated Apr 20, 2026) |
| Status | Open, Classified |
| Reason | Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off. |
| Root cause | Component design/selection |
| Action | On April 20, 2026 Shimadzu Medical Systems USA issued a Urgent: Voluntary Medical Device Recall Notification via E-Mail. Shimadzu asked consignees to take the following actions: 1. If your site is on the applicable list, please schedule time with your Distributer to have your system updated. 2. Shimadzu requests that you post this letter within your facility so that all users are aware of how to avoid this issue until the corrective actions have been completed. 3. If there are any issues, please report them to your respected distributor. 4. Please complete the acknowledgement form below. |
| Quantity | 3487 units |
| Distribution | Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Canada, The Bahamas, China, Denmark, H |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062360 | BRANSIST SAFIRE Shimadzu Corp., Oct 5, 2006 |
| K123508 | TRINIAS Shimadzu Corporation, Feb 26, 2014 |
| K152244 | RADspeed Pro Shimadzu Corporation, Jun 20, 2016 |
| K203535 | Trinias Shimadzu Corporation Medical Systems, Apr 28, 2021 |
| K221922 | Trinias Shimadzu Corporation Medical Systems Division, Jul 28, 2022 |
| K233722 | RADspeed Pro Shimadzu Corporation, Feb 23, 2024 |