Alaris PC unit recall: Software Issue
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply…
Why was Alaris PC unit recalled?
The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID module for a continuous infusion with a bolus dose option may result in a loss of information from the Guardrails Data s
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
not available
- Product
- Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply…
- Recalling firm
- Carefusion Corporation
- Quantity
- 4,090 total units
- Distribution
- Worldwide Distribution USA Nationwide and the countries of Australia and Canada.
- Recall date
- April 24, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)