Z-2077-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 31, 2019
- Initiation Date
- June 5, 2019
- Termination Date
- April 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7
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
Reason for Recall
The monitor displays an error message . The error message states "internal error restart or service".
Distribution Pattern
US Nationwide distribution in the states of MD, OK, NY,FL, SC
Code Information
software version:V5.1.0.7 US ver. A., Serial number affected: K17400011005 , K17400011065, K17400011082, K17400011086, K17400011097, K17400011107, L17400011267.