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.

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.