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Health product recall

Spectrum Infusion Pump (V8.00.02)

Starting date:
January 27, 2017
Posting date:
February 14, 2017
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-62194

Reason

Software V8.00.02 contains an anomaly that may cause a "sharp watchdog timeout" error message when a message is being written to the pump's event history log, and the length of that message exactly matches the size of the available memory at the end of a memory sector. The software anomaly may result in a delay or interruption in therapy while an alternative pump is obtained.

Affected products

Spectrum Infusion Pump (V8.00.02)

Lot or serial number

More than 100 numbers, contact manufacturer

Model or catalog number

35700BAX2

Companies

Manufacturer
Baxter Healthcare Corporation
711 Park Ave.
Medina
14103
New York
UNITED STATES