Boston Scientific myLUX Patient Application Recalled for Data Transmission Failure
Boston Scientific is recalling the myLUX Patient Application for Apple mobile devices because it may fail to transmit cardiac monitor data to the LATITUDE Clarity website.
What this means for you
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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (cardiac monitor) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Boston Scientific Corporation is recalling the myLUX Patient Application for Apple mobile devices, Model Number 2939, Versions 2.0.101 and 2.0.110. The recall involves 7,649 apps distributed nationwide to specific states and Puerto Rico.
The recall was initiated because patients using the application may not be transmitting data from their Insertable Cardiac Monitor to the LATITUDE Clarity website. This failure in data transmission could prevent healthcare providers from receiving necessary cardiac monitoring information.
Affected users should contact Boston Scientific or their healthcare provider for instructions on how to resolve the data transmission issue. The agency has classified this as a Class II recall, indicating a situation where use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 7,649
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 (3)
- GTIN 00802526618215
- Versions 2.0.101
- 2.0.110
Distribution
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