CLASS II Device recall · Reported 31 Jul 2019 · FDA Enforcement Report
PulsioFlex Monitoring System recalled by Getinge Us Sales
Getinge US Sales is recalling PulsioFlex Monitoring System, distributed nationwide in the US. The recall was initiated on 5 Jun 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2077-2019
- FDA event ID
- 83233
- Recalling firm
- Getinge US Sales, WAYNE, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jun 2019
- FDA classified
- 25 Jul 2019
- Reported
- 31 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 5 Jun 2019 | Recall initiated by company | |
| 25 Jul 2019 | Classified by FDA | +50 days |
| 31 Jul 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The monitor displays an error message . The error message states "internal error restart or service".
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution in the states of MD, OK, NY,FL, SC
Questions about this recall
Why was it recalled?
The monitor displays an error message . The error message states "internal error restart or service".
Which lots are affected?
software version:V5.1.0.7 US ver. A., Serial number affected: K17400011005 , K17400011065, K17400011082, K17400011086, K17400011097, K17400011107, L17400011267.
Where was it sold?
US Nationwide distribution in the states of MD, OK, NY,FL, SC
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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