Terumo Advanced Perfusion System 1 Electronic Patient Gas System Recall
Terumo is recalling 152 Advanced Perfusion System 1 Electronic Patient Gas Systems because the service manual was not updated for software version 1.30.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the issue is a documentation error (service manual not updated) and does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 152 units of the Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188. The recall is due to the service manual not being updated at the time of the release of software version 1.30.
The affected products were distributed nationwide in the United States to the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, MI, MN, MO, OH, OR, PA, SC, TN, TX, WA, and WI, as well as Puerto Rico. The products were also distributed to numerous foreign countries, including Australia, Canada, China, France, Germany, India, Japan, and others.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 152
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All systems. UDI 00886799000588
Distribution
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