Terumo Advanced Perfusion System 1 Electronic Patient recall
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Why was Terumo Advanced Perfusion System 1 Electronic Patient recalled?
intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
S/N: 01751 UDI: 00886799000588
- Product
- Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 1 unit OUS
- Distribution
- International distribution in the country of Panama.
- Recall date
- September 1, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)