FDA recall Z-2077-2019

GETINGE US SALES LLC · Class II · device

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

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-06-05
Report date
2019-07-31
Termination date
2020-04-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
WAYNE, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2077-2019