[Recalled] Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. — Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports sin
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. |
|---|---|
| Brand / manufacturer | Terumo Cardiovascular Systems Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0050-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 25 September 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns" Centrifugal System. The reports can be broadly categorized as follows: " Failure to charge " Failure to hold charge " Failure to operate In the most severe case, a battery malfunction could result in an unexpected loss of arterial flow. In
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Terumo Cardiovascular Systems Corporation
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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