FDA recall, , Moderate risk
Shimadzu Trinias Opera Smart, Opera Grand and Smart OBL Interventional Fluoroscopic X-Ray Systems
The mounting bolts securing the C-arm drive unit may not be torqued to specification.
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION began this recall on Sep 30, 2025. FDA posted it on Nov 3, 2026; it is still open. Still check yours.
Summary by Recall Canary from the FDA notice
What happened
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION of Kyoto, Japan, voluntarily initiated a recall of its 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. The recall was added to the FDA's Enforcement Report and classified on November 3, 2026.
The recall began on September 30, 2025, and customers were notified by e-mail. The product was distributed nationwide in the states of SC, TX, FL, TN, CA, FL, and NY.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and other code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
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),
- UDI-DI
- 04540217067145
- Other code
- M1F0D3BF4001
- SMS20250167
- 250
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Nov 2, 2026
- Sold in
US Nationwide distribution in the states of South Carolina, Texas, Florida, Tennessee, California, Florida, New York.
- Recalled by
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISIONKyoto, Japan
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 100044
- Recall number
- Z-0347-2027
- Quantity recalled
- 118 unts.
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
All recalls from SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
