Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported February 1, 2023
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
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 concentr…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Getinge Usa Sales Inc recalled Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 667… - a critical-severity action.
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 667… was recalled by Getinge Usa Sales Inc in February 1, 2023. Reason: Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If …. Check the official notice for the remedy. Verify recall #Z-0959-2023 with the FDA Devices before acting.
The recall
Getinge Usa Sales Inc issued this critical-severity FDA Devices recall-Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If ….
- Critical
- severity level
- Class I
- classification
- February 1, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0959-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0959-2023) was formally reported on February 1, 2023, with the manufacturer initiating the action on December 22, 2022. It is classified under Critical severity (Class I), with a current status of Ongoing. Getinge Usa Sales Inc is listed as the recalling firm, operating out of Wayne, NJ. Federal records list the affected scope as 8,016 Total (7,766 OUS; 250 US).
The documented reason for this recall is: 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 hy… Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
8,016 Total (7,766 OUS; 250 US)
Related Recalls
6
3 from same agency
Product description
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0959-2023 |
| Date reported | February 1, 2023 |
| Date initiated | December 22, 2022 |
| Recalling firm | Getinge Usa Sales Inc |
| Firm location | Wayne, NJ |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0959-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400. Recalled by Getinge Usa Sales Inc. Units affected: 8,016 Total (7,766 OUS; 250 US).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 1, 2023. Severity: Critical. Recall number: Z-0959-2023.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0959-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 1, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.