GE Healthcare Centricity Cardiology AI1000 Workstation version 4.2.6 and version 4.2.7.05
FDA device recall Z-1421-05 · posted 2005-08-30 · Terminated
Recall details
- Recalling firm
- GE Medical Systems Information Technologies
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 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
- Date initiated
- 2005-07-18
- Date posted
- 2005-08-30
- Date terminated
- 2006-07-22
- Location
- Mount Prospect, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANALYTICAL REVIEW STATION (K955519) | Camtronics, Ltd. | 1996-05-09 |