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 f Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 f
Brand
GETINGE US SALES LLC
Lot Codes / Batch Numbers
software version:V5.1.0.7 US ver. A., Serial number affected: K17400011005, K17400011065, K17400011082, K17400011086, K17400011097, K17400011107, L17400011267.
Products Sold
software version:V5.1.0.7 US ver. A., Serial number affected: K17400011005 , K17400011065, K17400011082, K17400011086, K17400011097, K17400011107, L17400011267.
GETINGE US SALES LLC is recalling PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioF due to The monitor displays an error message . The error message states "internal error restart or service".. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The monitor displays an error message . The error message states "internal error restart or service".
Recommended Action
Per FDA guidance
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)
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026