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Recall Observatory FDA recall evidence

Device product

Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.

Z-1478-2018

January 19, 2018

Class II

Product summary

Firm
Terumo Cardiovascular Systems Corporation
Event
Event 79624
Status
Terminated
Classification
Class II
Quantity
7
Official record key
device-enforcement:Z-1478-2018

Official wording

Reason: 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).

Code information: Catalog # - 802018 Serial #: 01662, 01672, 01680, 01681,01682, 01683 , and 01687. UDI: 00886799000687.

Distribution pattern: Worldwide Distribution -- USA, including the states of IL, KY, and MI; and, the country of Singapore.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).