The Recall Desk
HighFDA (Devices)·Z-2262-2024·Announced 2024-07-10

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.

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: 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
Hazard
  • software-defect
  • connectivity-loss

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

Distributed nationwide across the United States.

Related recalls

Same category