Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PulsioFlex Monitoring System Recalled by GETINGE US SALES LLC Due to The monitor displays an error message . The...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact GETINGE US SALES LLC directly.
Affected Products
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
Quantity: 7
Why Was This Recalled?
The monitor displays an error message . The error message states "internal error restart or service".
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About GETINGE US SALES LLC
GETINGE US SALES LLC has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report