BD Alaris System Manager Software Connectivity Issue Recalled Nationwide
A software issue in BD Alaris System Manager version 12.5.1 may prevent the PC unit from connecting to the server, potentially affecting wireless data transmission. CareFusion 303, Inc. is recalling the affected software version nationwide.
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: This FDA Class II medical device software defect poses a risk to wireless data transmission in clinical settings. No injuries or hospitalizations have been reported in the source text, making this a risk-of-harm product without reported injury, consistent with a severity score of 3.
Plain-English summary
BD Alaris System Manager software version 12.5.1 has a software defect that may prevent the PC unit from connecting to the server. This connectivity issue could impact wireless data transmission to and from the server in healthcare facilities where this system is deployed.
The affected software is version 12.5.1, identified by UDI 10885403960123. The product has been distributed nationwide throughout the United States, including in all 50 states and Puerto Rico.
CareFusion 303, Inc. is recalling the affected software version due to this connectivity issue.
The recalled product
- Product
- BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device
- Affected units
- 168
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 (1)
- UDI: 10885403960123/ Software versions 12.5.1
Distribution
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