Flow-e Anesthesia System, model 6887900

FDA device recall Z-0991-2024 · posted 2024-02-06 · Open, Classified

Recall details

Recalling firm

Getinge Usa Sales Inc

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.

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.

Root cause

Software design

Status

Open, Classified

Product code

BSZ

Quantity affected

86 (US)

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.

Date initiated

2023-12-11

Date posted

2024-02-06

Location

Wayne, NJ

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