Reported Jun 3, 2015 · Terminated
100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for…
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 Rd · Ann Arbor, MI · 48103-9586
Is this the product you have?
- 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on 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 All serial number units
- Amount recalled
- 1713 units total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Terumo CVS is implementing field correction activities to address the identified causes of the Terumo System 1 experiencing loss of system power. These activities will be implemented in a phased approach beginning late 2015: - Implementing design changes and upgrades to improve the reliability of power switching and battery backup. - Adding a switch protector to the On/Off power switch to preven
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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