GETINGE US SALES LLC: 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

Recall number

Z-2077-2019

Recalling firm

GETINGE US SALES LLC

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

Status

Terminated

Initiated

2019-06-05

Posted

not on file

Terminated

2020-04-24

Reason

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

Root cause

Software design

Action

PULSION Medical Systems SE /Getinge issued a customer notification (i.e. Urgent Medical Device correction/ Removal) to the affected US consignees via FedEx Priority Overnight Delivery with Signature Proof of Delivery. 1. Examine your inventory immediately to determine if you have any affected PulsioFlex Monitors. 2.Should you have one or more PulsioFlex Monitors you will need to return the device(s) for service. 3. contact PULSION Medical Systems SE/Getinge Sales Support at 1-888-627-8383 (press option 2, then option 2) to request a return authorization (RMA) and shipping instructions to return any affected product. 4. Please complete and sign the attached MEDICAL DEVICE RECALL (REMOVAL) - RESPONSE FORM (page 4) to acknowledge that you have received this notification. 5. Return the completed form to PULSION Medical Systems SE/Getinge Sales Support by e-mailing a scanned copy to PulsioFlex2019@getinge.com or by faxing the form to 1-800-862-5307. If you have any questions, please contact PULSION Medical Systems SE/Getinge Sales Support at 1-888-627-8383 (press option 2, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone)

Quantity

7

Distribution

US Nationwide distribution in the states of MD, OK, NY,FL, SC

Lot, serial or model codes

software version:V5.1.0.7 US ver. A.,   Serial number affected: K17400011005 , K17400011065, K17400011082, K17400011086, K17400011097, K17400011107, L17400011267.

510(k) numbers

["K172259"]

PMA numbers

not on file

Product code

DXG

Firm FEI

3012092534

Firm city

WAYNE

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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