Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-

FDA device recall Z-2294-2026 · posted 2026-06-02 · Open, Classified

Recall details

Recalling firm

Shimadzu Medical Systems

Reason for recall

Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.

Action taken

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. 5. For additional safety measures, please see customer notification.

Root cause

Component design/selection

Status

Open, Classified

Product code

OWB

Quantity affected

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

Date initiated

2026-04-20

Date posted

2026-06-02

Location

Long Beach, CA

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