FDA-Device2018-05-02Class II
Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
Terumo Cardiovascular Systems Corporation
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).
Sold states
Worldwide Distribution -- USA, including the states of IL, KY, and MI; and, the country of Singapore.
Affected count
7
Manufactured in
6200 Jackson Rd, N/A, Ann Arbor, MI, United States
Products
Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1478-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief