Health product recall

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

  1. Alaris System - Server Mobile Systems Manager
  2. Alaris System - PCA Module
  3. Alaris System - Pump
  4. 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