Recall Z-2077-2019 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
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 th
| Date | Jun 5, 2019 |
| Status | Terminated |
| 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 retu |
| Quantity | 7 |
| Distribution | US Nationwide distribution in the states of MD, OK, NY,FL, SC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172259 | PulsioFlex Monitoring System Pulsion Medical Systems SE, Jan 18, 2018 |