GETINGE US SALES LLC: Medical Device Recall in 2019 - (Recall #: Z-2077-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 5, 2019

Date Posted: July 31, 2019

Recall Number: Z-2077-2019

Event ID: 83233

Reason for Recall:

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

Status: Terminated

Product Quantity: 7

Code Information:

software version:V5.1.0.7 US ver. A., Serial number affected: K17400011005 , K17400011065, K17400011082, K17400011086, K17400011097, K17400011107, L17400011267.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated