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GETINGE US SALES LLC recalls PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring Syste
Recalled July 31, 2019 · FDA recall Z-2077-2019 · GETINGE US SALES
Hazard
The monitor displays an error message . The error message states "internal error restart or service". · FDA Class II
Units
7
Sold at
US Nationwide distribution in the states of MD, OK, NY,FL, SC
Description
The monitor displays an error message . The error message states "internal error restart or service".
Product
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
Manufacturer(s)
GETINGE US SALES LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →