Data Foundry

Medical device recalls 2026

Digital Angiography System Trinias:UD150G-40 / D150GC-40 — Class II medical device recall Z-2294-2026

Ongoing recall by Shimadzu Medical Systems, reported 2026-06-10, distributed nationwide. Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplie

Recall numberZ-2294-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmShimadzu Medical Systems, Long Beach, CA, United States
Recall initiated2026-04-20
Classified2026-06-02
Reported by FDA2026-06-10
DistributedNationwide (US)
Countries outside the USBS, CA, CN, DK, HT
Quantity3,487 units
Serial numbers001, 0161Q81103, 0161Q81704, 0161Q82204, 0161Q82302, 0161Q82304, 0161Q83003, 0161Q83204, 0161Q83603, 0161Q83702, 0161Q83703, 0161Q84501, 0162R70207, 0162R71501, 0162R71502, 0162R71505, 0162R71604, 0162R71605, 0162R71701, 0162R71702, 0162R71703, 0162R71704, 0162R71705, 0162R71801, 0162R71802 and 475 more

Product

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 safire: UD150B-40 / D150BC-40; Radiography System RADspeed fit: N/A (Integrated in the system); X-RAY R/F SYSTEM SONIALVISION safire17:UD150B-40 / D150BC-40; X-RAY R/F SYSTEM SONIALVISION safire Plus: UD150B-40 / D150BC-4;0 X-RAY R/F SYSTEM SONIALVISION safire: UD150B-40 / D150BC-40; X-RAY R/F SYSTEM SONIALVISION VERSA: UD150B-40 / UD150V-40 / UD150L-40/D150BC-40 / D150VC-40 / D150LC-40; X-RAY R/F SYSTEM FLUOROspeed 300:UD150B-40 / UD150V-40 / UD150L-40/D150BC-40 / D150VC-40 / D150LC-40; X-RAY R/F SYSTEM SONIALVISION G4:D150BC-40S; X-RAY R/F SYSTEM FLUOROspeed X1:D150BC-40S

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2294-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.