PulsioFlex Monitoring System — Class II medical device recall Z-2077-2019
Terminated recall by GETINGE US SALES LLC, reported 2019-07-31, distributed nationwide. The monitor displays an error message . The error message states "internal error restart or service".
| Recall number | Z-2077-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GETINGE US SALES LLC, WAYNE, NJ, United States |
| Recall initiated | 2019-06-05 |
| Classified | 2019-07-25 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2020-04-24 |
| Distributed | Nationwide (US) |
| Quantity | 7 |
| Model numbers | 6882747, PC400 |
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".
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.