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U.S. Department of Health and Human Services

Class 1 Device Recall Getinge Flowc

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 Class 1 Device Recall Getinge Flowcsee related information
Date Initiated by FirmDecember 22, 2022
Date PostedJanuary 26, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0960-2023
Recall Event ID 91339
510(K)NumberK191027 
Product Classification Gas-machine, anesthesia - Product Code BSZ
ProductGetinge Flow-c Anesthesia System, Part No. 6887700
Code Information Part # UDI 6887700 07325710009765 Serial Numbers 4003-5078 Software versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3.
Recalling Firm/
Manufacturer		 Getinge Usa Sales Inc
1 Geoffrey Way
Wayne NJ 07470-2035
For Additional Information ContactStephanie Moretti
973-709-7170
Manufacturer Reason
for Recall		Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.
FDA Determined
Cause 2		Software Design Change
ActionOn December 22, 2022, the firm notified affected customers through Urgent Medical Device Correction letters. Customers were instructed to examine their inventory immediately to determine if they have any of the affected serial numbers. If you have an affected system running on software version 4.8.0 through 4.8.3, you may continue use of the device until the software is updated with the following considerations: 1. If during use, the device is switched from Automatic to Manual and it is found that the manual bag is empty the user can activate the Emergency ventilation or turn off/on the device to reset the disabled valves function. 2. Users may also use the resuscitator that is available in the Operating Room. Getinge will update the software to correct the issue free of charge. You can arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Customer Technical Support at (888) 9GETUSA / (888) 943 8872 (select option 1, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Quantity in Commerce8.016 Total (7.766 OUS; 250 US)
DistributionUS nationwide and Worldwide Distribution: Domestic distribution to AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA, WV. Foreign distribution worldwide.
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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