Breas Vivo 50 Home Care Ventilator Recalled for Keypad Malfunction
Breas Medical AB is recalling 846 Vivo 50 Home Care Ventilators because a keypad malfunction can cause the device to stop treatment without an alarm.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a malfunction can lead to unintended treatment termination without an alarm, posing a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Breas Medical AB is recalling 846 units of the Breas Vivo 50 Home Care Ventilator in the United States. The recall affects all Vivo 50 Ventilators (model numbers 215000 and 215016) equipped with firmware version 2.04. The devices were distributed nationwide in the United States and in numerous countries worldwide, including Argentina, Belgium, Chile, and the United Kingdom.
The recall is due to a potential keypad malfunction that can cause the device to erroneously interpret input as a Stop Treatment Instruction. In these situations, the ventilator may enter stand-by mode, causing connected accessories and monitoring equipment to stop functioning. Crucially, no alarm will sound or be registered when this unintended treatment termination occurs.
Consumers using these devices should contact Breas Medical AB for instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
- Manufacturer
- Breas Medical AB
- Category
- Medical Device — Ventilator
- Affected units
- 846
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All Vivo 50 Ventilators (215000
- 215016) with firmware version 2.04
Distribution
Distributed nationwide across the United States.
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