Infusion Pump Class II 4753 units

IMED Gemini PC-4 Volumetric Infusion Pump and Controller withVersion 1.85 Software:

a) PC-4 Infusion Pump, Model 1340, 110 volts;

b) PC-4 Infusion Pump, Model 1341, 220 volts.

Recall #Z-174/175-0.

REASON

Due to a software modification, the devices will stop infusing
and alarm if the processors receive conflicting or confusing messages.

CODE

All pumps that carry software version 1.85.

MANUFACTURER

Alaris Medical Systems, Inc., San Diego, California.

RECALLED BY

Manufacturer, by letter on September 22, 1999. Firm-initiated
field correction ongoing.

DISTRIBUTION

Nationwide and International.

QUANTITY

4,753 (model 1340, 110 volts) and 132 (model 1341, 220 volts)
pumps were distributed.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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