Health product recall

SIGMA SPECTRUM Infusion System (V8 Platform) (2020-11-26)

Starting date:
November 26, 2020
Posting date:
December 11, 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-74523



Last updated:
2020-12-10

Affected Products

SIGMA SPECTRUM Infusion System (V8 Platform)

Reason

Baxter Corporation is issuing an urgent medical device correction to the user level for the Spectrum Infusion Pumps due to a software error which may occur following the completion of a secondary infusion, during the programming of a repeat of that secondary infusion.

Affected products

SIGMA SPECTRUM Infusion System (V8 Platform)

Lot or serial number

All serial numbers.

Model or catalog number

35700BAX2

Companies
Manufacturer

Baxter Healthcare Corporation

711 Park Ave.

Medina

14103

New York

UNITED STATES