Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 22, 2015
Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment Instruction. An alarm will n…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Breas Medical Ab recalled Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care - a moderate-severity action.
Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care was recalled by Breas Medical Ab in July 22, 2015. Reason: Unintended treatment termination could result from a keypad malfunction in some situations. The device errone…. Check the official notice for the remedy. Verify recall #Z-2094-2015 with the FDA Devices before acting.
The recall
Breas Medical Ab issued this moderate-severity FDA Devices recall-Unintended treatment termination could result from a keypad malfunction in some situations. The device errone….
- Moderate
- severity level
- Class II
- classification
- July 22, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2094-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2094-2015) was formally reported on July 22, 2015, with the manufacturer initiating the action on November 7, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Breas Medical Ab is listed as the recalling firm, operating out of Molnlycke, N/A. Federal records list the affected scope as 846 US.
The documented reason for this recall is: Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment Instruction. An alarm will not sound, or be registered. Accessories … Distribution data in the federal record shows the product reached: Worldwide - United States Nationwide Distribution and the countries: Argentina, Belgium, Chile, Cyprus, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebano…. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
846 US
Related Recalls
6
3 from same agency
Product description
Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
Reason for recall
Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment Instruction. An alarm will not sound, or be registered. Accessories and monitoring equipment connected to the Vivo 50 will stop functioning as the device enters stand-by mode.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2094-2015 |
| Date reported | July 22, 2015 |
| Date initiated | November 7, 2014 |
| Recalling firm | Breas Medical Ab |
| Firm location | Molnlycke, N/A |
| Affected scope | 846 US |
| Distribution | Worldwide - United States Nationwide Distribution and the countries: Argentina, Belgium, Chile, Cyprus, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Netherl… |
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-2094-2015) 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? ▼
Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care. Recalled by Breas Medical Ab. Units affected: 846 US.
Why was this product recalled? ▼
Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment Instruction. An alarm will not sound, or be registered. Accessories and monitoring equipment connected to the Vivo 50 will stop functioning as the device enters stand-by mode.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 22, 2015. Severity: Moderate. Recall number: Z-2094-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide - United States Nationwide Distribution and the countries: Argentina, Belgium, Chile, Cyprus, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Netherlands, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, UAE and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2094-2015) 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
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 July 22, 2015. 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.