Reported Jul 18, 2012 · Terminated
System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in the…
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 Road · Ann Arbor, MI · 48103-9586
Is this the product you have?
- System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
- Lot codes and dates
- Catalog number801763
- and serial numbers
0011-03350337-06101001-10341037-104911001103-11061109-1445and 1447-1450
- Amount recalled
- approx. 993 units
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
Why it was recalled
Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during periods of system shutdown. The System 1 may falsely indicate a longer battery life than actual battery time remaining if not subjected to regular use, such as would occur with a backup system. This may result in unexpected system shutdown. Prolonged battery depletion may cause permanent battery damage.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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