Z-0989-2024Class II

Flow-i C40 Anesthesia System, model 6677400

Name: Z-0989-2024 Flow-i C40 Anesthesia System, model 6677400
Creator: Getinge Usa Sales Inc
Published: 2023-12-11
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2023-12-11 / Open, Classified / root cause: software

FDA source

Getinge Usa Sales Inc began a recall of Flow-i C40 Anesthesia System, model 6677400 on 2023-12-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0989-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-11
Posted: 2024-02-06
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Flow-i C40 Anesthesia System, model 6677400
Product code: BSZ Gas-Machine, Anesthesia
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 16 (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.
Product codes and lots: UDI-DI: 07325710001318, serial numbers (US): 5204, 5205, 5206, 5207, 5208, 5209, 5210, 5211, 7185, 7982, 7983, 8426, 8427, 8428, 8445, 8446.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0989-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0987-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-06
Z-0988-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-06
Z-0989-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-06
Z-0990-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-06
Z-0991-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-06

Product code BSZ

K133958Class IIFlow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB / cleared 2014-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)