Sep

1999

Infusion Pump Class II 4753 units

Amy Sellers

News

infusionpump, recall

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.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Infusion Pump Class II 4753 units

Amy Sellers

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