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U.S. Department of Health and Human Services

Class 2 Device Recall Flowi C30

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 Class 2 Device Recall Flowi C30see related information
Date Initiated by FirmDecember 11, 2023
Date PostedFebruary 06, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0988-2024
Recall Event ID 93736
510(K)NumberK133958 
Product Classification Gas-machine, anesthesia - Product Code BSZ
ProductFlow-i C30 Anesthesia System, model 6677300
Code Information UDI-DI: 07325710001363, serial numbers (US): 1058, 1060, 1167, 1201.
Recalling Firm/
Manufacturer		 Getinge Usa Sales Inc
1 Geoffrey Way
Wayne NJ 07470-2035
For Additional Information ContactGetinge Customer Service
888-943-8872
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionAn 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 Commerce4 (US)
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BSZ
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