| Date Initiated by Firm | September 30, 2025 |
|---|
| Date Posted | November 03, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0347-2027 |
|---|
| Recall Event ID |
100044 |
| 510(K)Number | K221922 K203535 |
|---|
| Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
| 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), |
|---|
| Code Information |
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
|
| FEI Number |
3002808139
|
Recalling Firm/
Manufacturer |
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Nishinokyo Kuwabara -Cho
Nakagyo-Ku; 1
Kyoto
Japan
|
| For Additional Information Contact | Mr. Joseph Zegarelli
8175-823-1305 |
|---|
Manufacturer 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. |
|---|
FDA Determined
Cause 2 | 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 in Commerce | 118 unts. |
|---|
| Distribution | US Nationwide distribution in the states of SC, TX, FL, TN, CA, FL, NY. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = OWB
510(K)s with Product Code = OWB
|
|---|
