Breas Medical AB Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
Brand
Breas Medical AB
Lot Codes / Batch Numbers
All Vivo 50 Ventilators (215000, 215016) with firmware version 2.04
Products Sold
All Vivo 50 Ventilators (215000, 215016) with firmware version 2.04
Breas Medical AB is recalling Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care due to Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 13, 2026