FDA Device recall Z-2094-2015
Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
- FDA Device
- Class II
- terminated
- Published 2015-07-22
On 2015-07-22 the FDA classified a Class II recall of Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care by Breas Medical Ab, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2094-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-07 |
| Published | 2015-07-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Breas Medical Ab |
| Distribution | US |
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.
Identifiers
| code_info | All Vivo 50 Ventilators (215000, 215016) with firmware version 2.04 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2094-2015%22
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