GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington,
FDA device recall Z-1826-2008 · posted 2008-09-02 · Terminated
Recall details
- Recalling firm
- GE Healthcare Integrated IT Solutions
- Reason for recall
- A software anomaly results in incorrect study date and time information being displayed in the report screen and title, which may result in a potential patient misdiagnosis.
- Action taken
- GE Healthcare IITS sent Product Safety Notification letters dated 5/5/08 to all customers who have the GE Centricity PACS Software Versions 3.0.0.X, 3.0.1.X, 3.0.2.X and 3.0.3.X informing them of the incorrect study date and time information being displayed in the report screen and title, which may lead to a potential patient misdiagnosis. The users were instructed to refer to the image overlay for the correct date and time until the new software version can be installed. A software patch to permanently resolve the issue will be installed at no charge. Any questions were directed to the GE Customer Care Center at 800-437-1171.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 177 units
- Distribution
- Nationwide and internationally to Australia, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Malta, South Korea, Spain, Switzerland and United Kingdom.
- Date initiated
- 2008-05-06
- Date posted
- 2008-09-02
- Date terminated
- 2010-02-03
- Location
- Barrington, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CENTRICITY PACS SYSTEM (K043415) | Ge Medical Systems Information Technologies | 2005-01-21 |