Z-2077-2019Class II

PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex...

Name: Z-2077-2019 PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex...
Creator: Getinge US Sales Llc
Published: 2019-06-05
License: https://open.fda.gov/license/

Getinge US Sales LLC / initiated 2019-06-05 / Terminated / root cause: software

FDA source

GETINGE US SALES LLC began a recall of PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where... on 2019-06-05. FDA classified it as Class II and gives the reason as "The monitor displays an error message . The error message states "internal error restart or service"". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2077-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-05
Posted: 2019-07-25
Terminated: 2020-04-24
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
Product code: DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Reason for recall: The monitor displays an error message . The error message states "internal error restart or service".
Root cause tag: software
FDA 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 [email protected] 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 in commerce: 7
Distribution: US Nationwide distribution in the states of MD, OK, NY,FL, SC
Product codes and lots: software version:V5.1.0.7 US ver. A., Serial number affected: K17400011005 , K17400011065, K17400011082, K17400011086, K17400011097, K17400011107, L17400011267.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2077-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2077-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-25

Product code DXG

K172259Class IIPulsioFlex Monitoring SystemPulsion Medical Systems SE / cleared 2018-01-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)