Recall Z-1421-05 ยท LLZ System, Image Processing, Radiological
GE Medical Systems Information Technologies
GE Healthcare Centricity Cardiology AI1000 Workstation version 4.2.6 and version 4.2.7.05
| Date | Aug 30, 2005 (initiated Jul 18, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root 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 | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955519 | ANALYTICAL REVIEW STATION Camtronics, Ltd., May 9, 1996 |