Class 2 Device Recall GE Healthcare Centricity Cardiology workstation AI1000

• Date Initiated by Firm: July 18, 2005
• Date Posted: August 30, 2005
• Recall Status: Terminated on July 22, 2006
• Recall Number: Z-1421-05
• Recall Event ID: 32707
• 510(K)Number: K955519
• Product Classification: System, Image Processing, Radiological - Product Code LLZ
• Product: GE Healthcare Centricity Cardiology AI1000 Workstation version 4.2.6 and version 4.2.7.05
• Code Information: Centricity Cardiology AI1000 Software versions 4.2.6 and 4.2.7.05
• Recalling Firm/ Manufacturer: GE Medical Systems Information Technologies; 800 E Business Center Dr; Mount Prospect IL 60056-2178
• Manufacturer Reason for Recall: The potential exists for the AI1000 workstation to mix images from one study with images from another study. Mixed studies could be from the same patient or from different patients. Mixed patient images could compromise patient condition or diagnosis and treatment.
• FDA Determined Cause: Other
• Action: An Urgent Medical Device Corrrection letter, DATED?, was sent to customers listing procedures to take to minimize the possibility of mixed patient images until a permanent software upgrade is installed. Installation of new software can be done by the customer or by a GE Service Representative. A Customer Reply Form accompanies the letter for customers to indicate the location, serial no., system ID, software version of their AI100 Cardiac Review Workstation; and to indicate their upgrade option, either self or GE Service.
• Quantity in Commerce: 1,287
• Distribution: Outside the US to Austria, Australia, Canada, France, Germany, Italy, Japan, Korea, Malaysia, Norway, Spain, Switzerland, Taiwan, Thailand and United Kingdom. Within the US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and WI
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LLZ