Reported Jul 22, 2015 · Terminated
Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
Breas Medical AB
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Breas Medical AB · Foretagsvagen 1 · Molnlycke, N/A · N/A
Is this the product you have?
- Breas Vivo 50
- Home Care Ventilator Product UsageRespiratory Care
- Lot codes and dates
All Vivo 50 Ventilators (215000215016) with firmware version 2.04
- Amount recalled
- 846 US
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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