Class 2 Device Recall PulsioFlex Monitor

• Date Initiated by Firm: June 05, 2019
• Create Date: July 25, 2019
• Recall Status: Terminated on April 24, 2020
• Recall Number: Z-2077-2019
• Recall Event ID: 83233
• 510(K)Number: K172259
• Product Classification: Computer, diagnostic, pre-programmed, single-function - Product Code DXG
• 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
• Code Information: software version:V5.1.0.7 US ver. A., Serial number affected: K17400011005 , K17400011065, K17400011082, K17400011086, K17400011097, K17400011107, L17400011267.
• Recalling Firm/ Manufacturer: GETINGE US SALES LLC; 45 BARBOUR POND DR; WAYNE NJ 07470
• For Additional Information Contact: Allison Jean Kaplan; 973-7097779
• Manufacturer Reason for Recall: The monitor displays an error message . The error message states "internal error restart or service".
• FDA Determined 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 in Commerce: 7
• Distribution: US Nationwide distribution in the states of MD, OK, NY,FL, SC
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DXG and Original Applicant = PULSION Medical Systems SE