Terumo¿ Advanced Perfusion System 1 Electronic Patient recall: Software Issue
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Why was Terumo¿ Advanced Perfusion System 1 Electronic Patient recalled?
The service manual was not updated at the time of the release of software version 1.30.
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?
All systems. UDI 00886799000588
- Product
- Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 152
- Distribution
- US Nationwide in the states of: AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, MI, MN, MO, OH, OR, PA, SC, TN, TX, WA, WI, and Puerto Rico. The products were distributed to the following foreign countries: Antioquia, Australia, Bangkok, Bangladesh, Belgium, Canada, Chile, China, Columbia, Dominican Republic, Ecuador, El Salvador, France, Germany, Guatemala, India, Indonesia, Japan, Korea, Kuwait, Malaysia, Metro Manilla, Mexico, New Delhi, New Zealand, Panama, Philippines, Singapore, South Africa, Sri Lanka, Taiwan, Thailand, and Vietnam.
- Recall date
- October 24, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)