Class I Hospira GemStar Docking Station

Company: Hospira Inc..
Date of Enforcement Report:5/7/2014
Class I:


GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX Recall Number Z-1512-2014

There are two situations that may occur when using the GemStar Docking Station, List Number 13075-XX-XX, in conjunction with the GemStar infusion pump: 1) when the Docking Station is used in conjunction with a GemStar Phase 3 pump (List 13000-XX, 13100-XX, or 13150-XX) the potential exists for the GemStar Phase 3 pump to fail to power up while connected to the Docking Station, and 2) when either a GemStar Phase 3 (List 13000-XX, 13100-XX, or 13150-XX)or GemStar Phase 4 pump (List 13086-XX, 13087-XX, or 13088-XX) is used in conjunction with both a Docking Station and an External Battery Pack accessory (List 13073-XX) there exists a possibility that the GemStar pump will display error code 11/003 and give an audible alarm indicating excessive input voltage from the external sources. If the GemStar pump detects what is perceived to be more than 3.6 Volts measured on the external voltage input, the pump will stop the infusion and alarm both with an audible sound as well as a visual alarm.

Hospira Inc., Lake Forest, IL. on 2/18/2014.

26,765 docking stations total (6866 in US)

Nationwide and Internationally


About the author

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.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.