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Recall Observatory FDA recall evidence

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

Z-2077-2019

June 05, 2019

Class II

Product summary

Firm
GETINGE US SALES LLC
Event
Event 83233
Status
Terminated
Classification
Class II
Quantity
7
Official record key
device-enforcement:Z-2077-2019

Official wording

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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