GETINGE US SALES LLC recalls PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System i…

Recall date

June 5, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2077-2019

FDA classification

Class II

Brand / firm

GETINGE US SALES LLC

Sold / distributed

US Nationwide distribution in the states of MD, OK, NY,FL, SC

Why it was recalled

The monitor displays an error message . The error message states "internal error restart or service".

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the PulsioFlex Monitor presents the derived parameters indexed. ¿ -With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters. -With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption. The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital units