Shimadzu X-ray systems recalled for possible loose C-arm bolts
The recall covers 118 Shimadzu Trinias Opera Smart, Opera Grand and Smart OBL interventional fluoroscopic X-ray systems with C-arm support. The mounting bolts securing the C-arm drive unit may not be torqued to specification, potentially compromising structural stability and safe operation. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Contact Shimadzu Corporation Medical Systems Division about the C-arm drive unit mounting bolts, since the notice does not say how to check or fix them.
- Check whether your system's serial number matches the list in the notice, such as M1F0D3BF4001 or 41F0F40E5001, or its UDI matches the listed codes.
- The notice doesn't say how to get a repair or replacement; ask Shimadzu or the system's supplier for next steps.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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),
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 118 unts.
- Illnesses reported
- None reported
- Manufactured in
- Nishinokyo Kuwabara -Cho, Nakagyo-Ku; 1, Kyoto, Japan
- Classification
- Class II
- Recall number
- Z-0347-2027
In the FDA's words
- Description
- 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), 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. 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. Affected quantity: 118 unts.
- Hazard
- 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.