Trinias recall: Software Issue
Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography…
Why was Trinias recalled?
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Affected Serial Numbers: 41EFCD7A6001 41EFC73A5001, 41EFCD79C001, 41EFD3B9C001, 41EFFF79C001, 41EFD3B9A001, 41EFCD79A001, 41EFFF79A001, 41F005B91001, 41F005B8C001, 41EFCD78B001, 41EFCD77C001, 41E58C776001, 41E58C777001, 41E58C775001, 41E58C773001, 41E58C76B001, 41E58C769001, 41E58C766001, 41E58C765001, 41E58C757001, 41B24774C001, 41B247746001,
- Product
- Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography…
- Recalling firm
- Shimadzu Medical Systems
- Quantity
- 23 units
- Distribution
- US Nationwide distribution including in the states of KY, CA, MI, OH, CT, MI, NY, SC, NC,IN, IL, TN, LA, CT, MT.
- Recall date
- December 16, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)