Flow-i C40 Anesthesia System, model 6677400
This recall is currently active, issued February 6, 2024. It was issued by Getinge Usa Sales Inc.
- Company
- Getinge Usa Sales Inc
- Recall Initiated
- December 11, 2023
- Posted
- February 6, 2024
- Recall Number
- Z-0989-2024
- Quantity
- 16 (US)
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.
Distribution
Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA & WV.
Lot / Code Info
UDI-DI: 07325710001318, serial numbers (US): 5204, 5205, 5206, 5207, 5208, 5209, 5210, 5211, 7185, 7982, 7983, 8426, 8427, 8428, 8445, 8446.
Root Cause
Software design
Action Taken
An Urgent Medical Device Correction notice dated December 21, 2023 was issued via FedEx. The letter advises customers to examine inventory immediately to determine if you have any affected product. Directions are outlined for 1) Users with system version 4.8 and above with a Flow Anesthesia System connected to Connected Services directly via the Ethernet port on the Flow Anesthesia System (i.e., without a Getinge Connect module) and for 2) Users with system version 4.7 and below with Flow Anesthesia System connected to Remote Services via ethernet cable. Customers are asked to complete and return the MEDICAL DEVICE - CORRECTION RESPONSE FORM. Information should be forwarded to all current and potential system users with in your hospital / facility. Distributors are to forward the notification to customers for appropriate action. Contact your Getinge representative or call Getinge Customer Service at (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone) with questions.