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…
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 recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026