Reported Oct 24, 2018 · Terminated

Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188

Terumo Cardiovascular Systems Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Terumo Cardiovascular Systems Corporation · 6200 Jackson Rd · Ann Arbor, MI · 48103-9586

Is this the product you have?

  • Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Lot codes and dates
  • All systems. UDI 00886799000588
Amount recalled
152

Where it was sold

Why it was recalled

The service manual was not updated at the time of the release of software version 1.30.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 18, 2019 · Data as of Sep 19, 4:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.