Alaris System - Server Mobile Systems Manager, PCA Module, Pump & Syringe Pump Module (2020-02-04)
- Starting date:
- February 4, 2020
- Posting date:
- February 21, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-72379
Last updated: 2020-04-17
Affected Products
- Alaris System - Server Mobile Systems Manager
- Alaris System - PCA Module
- Alaris System - Pump
- Alaris System - Syringe Pump Module
Reason
Recall is being initiated to communicate the important user actions to help mitigate the potential risks for the following five issues until a new version of software is available: 1) software errors related to System Error Code 255-XX-XXX, 2) delay options programming, 3) low battery alarm failure, 4) keep vein open (KVO) / end of infusion alarms priority, and 5) use errors related to custom concentration programming.
Affected products
A. Alaris System - Server Mobile Systems Manager
Lot or serial number
- Software versions 9.33 and prior.
- Software versions 9.5 and prior.
- Software version 10.5 and prior.
Model or catalog number
- 8000
- 8015
Companies
- Manufacturer
-
Carefusion 303, Inc.
10020 Pacific Mesa Blvd.
San Diego
92121-2733
California
UNITED STATES
B. Alaris System - PCA Module
Lot or serial number
Software versions 9.33 and prior.
Model or catalog number
8120
Companies
- Manufacturer
-
Carefusion 303, Inc.
10020 Pacific Mesa Blvd.
San Diego
92121-2733
California
UNITED STATES
C. Alaris System - Pump
Lot or serial number
Software versions 9.33 and prior.
Model or catalog number
8100
Companies
- Manufacturer
-
Carefusion 303, Inc.
10020 Pacific Mesa Blvd.
San Diego
92121-2733
California
UNITED STATES
D. Alaris System - Syringe Pump Module
Lot or serial number
Software versions 9.33 and prior.
Model or catalog number
8110
Companies
- Manufacturer
-
Carefusion 303, Inc.
10020 Pacific Mesa Blvd.
San Diego
92121-2733
California
UNITED STATES