Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Check against the official notice below — it lists the full affected range.
Terumo Cardiovascular Systems Corporation is recalling 152 Terumo Advanced Perfusion System 1 Electronic Patient Gas Systems (Catalog #801188) because the service manual was not updated when software version 1.30 was released. The affected systems were distributed nationwide across 23 U.S. states and Puerto Rico, as well as to multiple foreign countries including Canada, Australia, Japan, Germany, France, China, India, and others.
The record does not specify a remedy for this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
The service manual was not updated at the time of the release of software version 1.30.
Reason for recall: The service manual was not updated at the time of the release of software version 1.30. 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, Mal Quantity: 152 Lot/code info: All systems. UDI 00886799000588
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.