| Class 1 Device Recall Getinge Flowi | |
Date Initiated by Firm | December 22, 2022 |
Date Posted | January 26, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0959-2023 |
Recall Event ID |
91339 |
510(K)Number | K191027 |
Product Classification |
Gas-machine, anesthesia - Product Code BSZ
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Product | Getinge Flow-i Anesthesia Systems
Flow-i C20, Part no. 6677200
Flow-i C30, Part no. 6677300
Flow-i C40, Part no. 6677400 |
Code Information |
Part # UDI
6677200 7325710001349
Serial Numbers 1202-8027
Part # UDI
6677300 7325710001363
Serial Numbers 1058-1201
Part # UDI
6677400 7325710001318
Serial Numbers 2034-8446
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
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For Additional Information Contact | Stephanie 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 |
Action | On 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 Commerce | 8,016 Total (7,766 OUS; 250 US) |
Distribution | US 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 Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = BSZ
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