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Flow-c Anesthesia System, model 6887700 recallZ-0990-2024 · Getinge Usa Sales Inc · initiated Dec 11, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Getinge Usa Sales Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-0990-2024
Status
Open, Classified
Initiated by the company
Dec 11, 2023
Posted by the FDA
Feb 6, 2024
Recalling firm
Getinge Usa Sales Inc
Quantity
14 (US)
Product code
BSZ
FDA submissions
K133958
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.

Product description

Flow-c Anesthesia System, model 6887700

Code information (models, lots, serial numbers)

UDI-DI: 07325710009765, serial numbers (US): 5024, 5025, 5026, 5027, 5028, 5043, 5044, 5045, 5046, 5047, 5048, 5049, 5050, 5078.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

2 devices cleared under K133958 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 93736).

Sources and updates

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