CLASS II Device recall · Reported 24 Oct 2018 · FDA Enforcement Report
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System recalled
Terumo Cardiovascular Systems is recalling Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, distributed nationwide in the US. The recall was initiated on 13 Sep 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0176-2019
- FDA event ID
- 81070
- Recalling firm
- Terumo Cardiovascular Systems, Ann Arbor, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Sep 2018
- FDA classified
- 18 Oct 2018
- Reported
- 24 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 13 Sep 2018 | Recall initiated by company | |
| 18 Oct 2018 | Classified by FDA | +35 days |
| 24 Oct 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The service manual was not updated at the time of the release of software version 1.30.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Where it was distributed
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, Malaysia, Metro Manilla, Mexico, New Delhi, New Zealand, Panama, Philippines, Singapore, South Africa, Sri Lanka, Taiwan, Thailand, and Vietnam.
Nationwide AlabamaArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIllinoisIndianaKansasKentuckyMichiganMinnesotaMissouriOhioOregonPennsylvaniaPuerto RicoSouth CarolinaTennessee
Questions about this recall
Why was it recalled?
The service manual was not updated at the time of the release of software version 1.30.
Which lots are affected?
All systems. UDI 00886799000588
Where was it sold?
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, Malaysia, Metro Manilla, Mexico, New Delhi, New Zealand, Panama, Philippines, Singapore, South Africa, Sri Lanka, Taiwan, Thailand, and Vietnam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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