Recall Z-2094-2015— Breas Medical AB
Class II · Terminated
Class II FDA medical device recall by Breas Medical AB, initiated 2014-11-07, terminated 2016-04-07. It names one FDA 510(k) clearance: K123144. Product: Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care. Reason: 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..
- Recalling firm
- Breas Medical AB
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-07
- Terminated
- 2016-04-07
- Firm location
- Molnlycke, N/A, Sweden
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.