Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.
Reported: July 6, 2016 Initiated: May 12, 2016 #Z-2064-2016
Product Description
Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.
Reason for Recall
A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110.
Details
- Recalling Firm
- CareFusion 303, Inc.
- Units Affected
- 69,693 units
- Distribution
- Distributed US (nationwide) and in Canada.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.. Recalled by CareFusion 303, Inc.. Units affected: 69,693 units.
Why was this product recalled? ▼
A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 6, 2016. Severity: Moderate. Recall number: Z-2064-2016.
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