# FDA recall Z-2077-2019

> **GETINGE US SALES LLC** · Class II · device recall initiated 2019-06-05.

## 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

- **Recall number:** Z-2077-2019
- **Recalling firm:** GETINGE US SALES LLC
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2077-2019. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-2077-2019. Source: US FDA. Licensed CC0.

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