GE Healthcare Centricity Cardiology AI1000 Workstation version 4.2.6 and version 4.2.7.05
- Recall Initiated
- July 18, 2005
- Posted
- August 30, 2005
- Terminated
- July 22, 2006
- Recall Number
- Z-1421-05
- Quantity
- 1,287
- Firm Location
- Mount Prospect, IL
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.
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
Lot / Code Info
Centricity Cardiology AI1000 Software versions 4.2.6 and 4.2.7.05
Root Cause
Other
Action Taken
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.