ModerateClass IIOngoing

FDA Devices recall · Reported October 20, 2021

Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on October 20, 2021. Severity: Moderate. Recall number: Z-0108-2022.

Q: 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.

Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 se…

Recall #: Z-0108-2022
Affected scope: 6,797 units
Initiated: September 10, 2021

Compiled from official public sources by the publisher. · Updated September 2026

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Draeger Medical, Inc. recalled Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation … - a moderate-severity action.

Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation … was recalled by Draeger Medical, Inc. in October 20, 2021. Reason: Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief…. Check the official notice for the remedy. Verify recall #Z-0108-2022 with the FDA Devices before acting.

The recall

Draeger Medical, Inc. issued this moderate-severity FDA Devices recall-Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief….

Moderate
severity level: 7K units
affected scope: Class II
classification: October 20, 2021
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0108-2022 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

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 moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400

Reason for recall

Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-0108-2022
Date reported	October 20, 2021
Date initiated	September 10, 2021
Recalling firm	Draeger Medical, Inc.
Firm location	Telford, PA
Affected scope	6,797 units
Distribution	US Nationwide

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

6,797 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0108-2022) 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.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼

Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400. Recalled by Draeger Medical, Inc.. Units affected: 6,797 units.

Why was this product recalled? ▼

Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on October 20, 2021. Severity: Moderate. Recall number: Z-0108-2022.

Where was the recalled product distributed? ▼

Distribution: US Nationwide.

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.

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 (Moderate), closest by report date among other firms and states.

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This recall: FDA Devices, reported October 20, 2021. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026