Device recall
Trinias Opera Smart (C16s, F12s)/Opera Grand(C12s,C16s, F12s)/Smart OBL Interventional Fluoroscopic X-Ray System containing C-arm support (MH-500, MH-60),
- Recall number
- Z-0347-2027
- Event id
- 100044
- Status
- Open, Classified
- FDA classification
- Class II
- Recalling firm
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- Posted
- Nov 3, 2026
- Initiated
- Sep 30, 2025
- Product code
- OWB
- Device type
- Interventional Fluoroscopic X-Ray System
- Reason
- The mounting bolts securing the C-arm drive unit of the X-ray system may not be torqued to specification, potentially compromising structural stability and safe operation.
- Root cause
- Process control
- Quantity
- 118 unts.
- Code info
- Serial number/Shimadzu Medical Systems #/UDI: M1F0D3BF4001/ SMS20250167/ (01)04540217067145(11)250; M1F0CC4EB001/ SMS20250098/ (01)04540217067022(11)241; M1F0D27EA001/ SMS20250001/ (01)04540217067138(11)241; 41F0F43E7001/ SMS20250034/ (01)04540217068951(11)240; M1F0D3BE7001/ SMS20250248/ (01)04540217067145(11)240; M1F0D3BE6001/ SMS20240196/ (01)04540217067145(11)240; 41F0F40E5001/ N/A/ (01)04540217068937(11)240; 41F0F41E5001/ N/A/ (01)04540217068944(11)240; 41F0F43E5001/ SMS20240236/ (01)04540217068951(11)240; M1F0CD7E4001/ SMS20240162/ (01)04540217067046(11)240; 41F0F41E1001/ SMS20240062/ (01)04540217068944(11)240; 41F0F43DB002/ SMS20240101/ (01)04540217068951(11)231; 41F0F43DB001/ SMS20240100/ (01)04540217068951(11)231; M1F0CD7D4001/ SMS20230178/ (01)04540217067046(11)230
- Distribution
- US Nationwide distribution in the states of SC, TX, FL, TN, CA, FL, NY.
- Location
- Kyoto, Japan