FDA Medical Device Recalls (openFDA)
Getinge Usa Sales Inc: Flow-i C30 Anesthesia System, model 6677300
- Recall number
- Z-0988-2024
- Recalling firm
- Getinge Usa Sales Inc
- Product
- Flow-i C30 Anesthesia System, model 6677300
- Status
- Open, Classified
- Initiated
- 2023-12-11
- Posted
- 2024-02-06
- Terminated
- not on file
- Reason
- 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
- 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
- 4 (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.
- Lot, serial or model codes
- UDI-DI: 07325710001363, serial numbers (US): 1058, 1060, 1167, 1201.
- 510(k) numbers
- ["K133958"]
- PMA numbers
- not on file
- Product code
- BSZ
- Firm FEI
- 3013876692
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28