Z-1421-05

GE Healthcare Centricity Cardiology AI1000 Workstation version 4.2.6 and version 4.2.7.05

Name: Z-1421-05 GE Healthcare Centricity Cardiology AI1000 Workstation version 4.2.6 and version 4.2.7.05
Creator: GE Medical Systems Information Technologies
Published: 2005-07-18
License: https://open.fda.gov/license/

GE Medical Systems Information Technologies, Inc. / initiated 2005-07-18 / Terminated

FDA source

GE Medical Systems Information Technologies began a recall of GE Healthcare Centricity Cardiology AI1000 Workstation version 4.2.6 and version 4.2.7.05 on 2005-07-18. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1421-05
Status: Terminated
Initiated: 2005-07-18
Posted: 2005-08-30
Terminated: 2006-07-22
Recalling firm: GE Medical Systems Information Technologies, Inc.
Product: GE Healthcare Centricity Cardiology AI1000 Workstation version 4.2.6 and version 4.2.7.05
Product code: LLZ System, Image Processing, Radiological
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 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 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
Product codes and lots: Centricity Cardiology AI1000 Software versions 4.2.6 and 4.2.7.05

Product code LLZ

K955519Class IIAnalytical Review StationCamtronics, Ltd. / cleared 1996-05-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)