FDA Devices recall · Reported August 31, 2022
Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000
Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms being triggered, and loss of ventilation. If the device stops ventilat…
Getinge Usa Sales Inc recalled Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n … - a critical-severity action.
Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n … was recalled by Getinge Usa Sales Inc in August 31, 2022. Reason: Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms …. Check the official notice for the remedy. Verify recall #Z-1560-2022 with the FDA Devices before acting.
The recall
Getinge Usa Sales Inc issued this critical-severity FDA Devices recall-Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms ….
- Critical
- severity level
- Class I
- classification
- August 31, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1560-2022 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
Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000
Reason for recall
Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms being triggered, and loss of ventilation. If the device stops ventilating due to this issue, it may lead to hypoventilation and consequently desaturation, with patient outcomes including hypoxemia and hypoxic injury, which might result in circulatory failure.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1560-2022 |
| Date reported | August 31, 2022 |
| Date initiated | July 20, 2022 |
| Recalling firm | Getinge Usa Sales Inc |
| Firm location | Wayne, NJ |
| Affected scope | 37000 (11089 US) |
| Distribution | Worldwide distribution. US nationwide, Poland, Spain, France, Germany, Czech Republic, Italy, Belgium, Estonia, Greece, Finland, Portugal, Netherlands, Romania, Austria, Slovakia, Lithuania, Ireland, Latvia, Norway, Sweden, Malaysia, China… |
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-1560-2022) 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