Recall Z-0347-2027 ยท OWB Interventional Fluoroscopic X-Ray System
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
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),
| Date | Nov 3, 2026 (initiated Sep 30, 2025) |
| Status | Open, Classified |
| 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 |
| 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. |
| Quantity | 118 unts. |
| Distribution | US Nationwide distribution in the states of SC, TX, FL, TN, CA, FL, NY. |
| FDA record | Open on fda.gov |