Trinias Opera Smart (C16s, F12s)/Opera Grand(C12s,C16s, F12s)/Smart OBL Interventional Fluoroscopic X-Ray System containing C-arm support (…
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION · 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 saf…
Open FDA's page for this record- Cfres ID
- 223189
- Product res number
- Z-0347-2027
- Event date initiated
- 2025-09-30
- Event date posted
- 2026-11-03
- Recall status
- Open, Classified
- Res event number
- 100044
- Product code
- OWB
- Product 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),
- Firm FEI number
- 3002808139
- Recalling firm
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- Address 1
- Nishinokyo Kuwabara -Cho 1 nishinokyo kuwabara cho nakagyo-ku
- City
- Kyoto
- Country
- Japan
- Additional info contact
- Mr. Joseph Zegarelli 8175-823-1305
- Root cause description
- Process control
- Product quantity
- 118 unts.
- Distribution pattern
- US Nationwide distribution in the states of SC, TX, FL, TN, CA, FL, NY.
- 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
- Reason for recall
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.
- Action
On September 30, 2026 Shimadzu Corp. issued a Urgent Medical Device Recall Notification to affected consignees via email. Shimadzu asked consignees to take the following actions; 1. If the bolts become loose, an abnormal noise will occur when moving the C-arm. Please check for abnormal noises during pre-study inspections. 2. If an abnormal noise is heard, please stop using the product and contact our service department. 3. Please complete the Medical Device Recall Customer Acknowledgement.
- K numbers
- K221922, K203535
- Harmonized identifiers (openFDA)
- Device name
- Interventional Fluoroscopic X-Ray System
- Medical specialty description
- Radiology
- Regulation number
- 892.1650
- Device class
- 2
- K number
- K243735, K170130, K253670, K221344, K220342, K173631, K180473, K243884, K211191, K200917, K050489, K211780, K212442, K231700, K101868, K181550, K173314, K251523, K163715, K123508, K181804, K240465, K032046, K231669, K130638, K172646, K062647, K203281, K052202, K181834, K002198, K212383, K033244, K230787, K160147, K961374, K123529, K181415, K222625, K233230 +285 more
- Registration number
- 3021059265, 3016438694, 3014391847, 2027467, 3038614464, 3010398867, 9681146, 3004785967, 3015223550, 3009196578, 3008632256, 3003202425, 3012761544, 1723170, 3001722928, 2243057, 3003768251, 3021561977, 3010703925, 3036666444, 3021027284, 3013184485, 3022378058, 3008284470, 3011713200, 3027373189, 3036255956, 3018094310, 8030233, 3006544299, 3016248538, 1225677, 3009973505, 1037955, 2133772, 3008363989, 3025394757, 2939520, 3030412764, 3014343100 +86 more
- FEI number
- 3021059265, 3016438694, 1000114111, 3014391847, 2027467, 3038614464, 3002808139, 3010398867, 3004785967, 3015223550, 3009196578, 3008632256, 3003202425, 3012761544, 3001722928, 2243057, 3002980729, 3003768251, 3021561977, 3010703925, 3036666444, 3021027284, 3013184485, 3022378058, 3008284470, 3011713200, 3027373189, 3036255956, 3018094310, 3006544299, 3016248538, 3009973505, 1037955, 1000132370, 3008363989, 3025394757, 2939520, 3030412764, 3014343100, 1000188474 +86 more