Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
FDA device recall Z-2094-2015 · posted 2015-07-16 · Terminated
Recall details
- Recalling firm
- Breas Medical AB
- 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.
- Action taken
- Breas Medical sent Urgent Release: Field Safety Notice letters dated November 7, 2014 and Field Safety Notice dated November 21, 2014 to their customers. The letters identified the affected product, problem and the actions to be taken.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NOU
- Quantity affected
- 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, Ja
- Date initiated
- 2014-11-07
- Date posted
- 2015-07-16
- Date terminated
- 2016-04-07
- Location
- Molnlycke, Sweden
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIVO 50 (K123144) | Ge Healthcare, Breas Medical AB | 2013-06-18 |