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FDA (Device enforcement)Recalled 2021-06-08closedclass ii

Terumo Cardiovascular Systems Corporation: Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188

Is my product affected?

Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188

  • UPC 00886799000588

Check against the official notice below — it lists the full affected range.

What happened

Terumo Cardiovascular Systems Corporation has recalled one unit of the Terumo Advanced Perfusion System 1 Electronic Patient Gas System (Catalog #801188, Serial Number 01751) distributed internationally in Panama. The device can experience an intermittent blender initialization fault that occurs either during start-up or during a calibration attempt after the 15-minute warm-up period.

When this fault occurs, the control sliders on the Central Control Monitor become disabled, leaving the gas system operable only through the local control knobs. The recall record does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs

Details from the source

Reason for recall: intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs Distribution: International distribution in the country of Panama. Quantity: 1 unit OUS Lot/code info: S/N: 01751 UDI: 00886799000588

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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