Home / Recalls / Medical Devices
Terumo Cardiovascular Systems Corporation recalls Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor a
Recalled May 2, 2018 · FDA recall Z-1478-2018 · Terumo Cardiovascular Systems
Hazard
Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation). · FDA Class II
Units
7
Sold at
Worldwide Distribution -- USA, including the states of IL, KY, and MI; and, the country of Singapore.
Description
Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation).
Product
Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
Manufacturer(s)
Terumo Cardiovascular Systems Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →