Recall record at a glance
| Official record | Z-0176-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Report date | Oct 24, 2018 |
| Recall initiation date | Sep 13, 2018 |
| Quantity | 152 |
| Location | Ann Arbor, MI, United States |
Official product description
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Why the product was recalled
The service manual was not updated at the time of the release of software version 1.30.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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