Summary
The FDA issued a Class I for Getinge Flow-c Anesthesia System, Part No. 6887700 by Getinge Usa Sales Inc. Reason: Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decr.
Details
Source
Device Recall
External ID
Z-0960-2023
Action Date
2023-02-01
Status
Ongoing
Category
device
Product Description
Getinge Flow-c Anesthesia System, Part No. 6887700
Lot/Code Info: Part # UDI 6887700 07325710009765 Serial Numbers 4003-5078 Software versions 4.8.0, 4.8.1, 4.8.2, and 4.8.3.
Quantity Affected: 8.016 Total (7.766 OUS; 250 US)
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-22
Company
Wayne, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Getinge Usa Sales Inc has 48 FDA actions in our database, including 48 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Getinge Usa Sales Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Getinge Usa Sales Inc have FDA actions?
Getinge Usa Sales Inc has 48 FDA actions in our database, including 48 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0960-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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