FDA Medical Device Recalls (openFDA)
GE Medical Systems Information Technologies: GE Healthcare Centricity Cardiology AI1000 Workstation version 4.2.6 and version 4.2.7.05
- Recall number
- Z-1421-05
- Recalling firm
- GE Medical Systems Information Technologies
- Product
- GE Healthcare Centricity Cardiology AI1000 Workstation version 4.2.6 and version 4.2.7.05
- Status
- Terminated
- Initiated
- 2005-07-18
- Posted
- 2005-08-30
- Terminated
- 2006-07-22
- 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, OR, PA, RI, SC, TN, TX, UT, VA, WA and WI
- Lot, serial or model codes
- Centricity Cardiology AI1000 Software versions 4.2.6 and 4.2.7.05
- 510(k) numbers
- ["K955519"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1419826
- Firm city
- Mount Prospect
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28