GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integrated IT Solutions, Barrington
FDA device recall Z-0460-2009 · posted 2008-12-13 · Terminated
Recall details
- Recalling firm
- GE Healthcare Integrated IT Solutions
- Reason for recall
- Software anomalies result in patient safety issues involving patient jacket content intermittently becoming unintentionally out of synchronization with the images being displayed, and involving Default Display Protocols (DDPs) which are used to layout images when displaying a study. If the user does not check the Study Date Time of the exam on the image title bar, then they may interpret the curr
- Action taken
- GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation customers via letter (Product Safety Notification) dated 9/25/08 of the software anomalies resulting in patient safety issues involving the patient jacket content intermittently becoming unintentionally out of synchronization with the images being displayed, and involving Default Display Protocols (DDPs) which are used to layout images when displaying a study. If the user does not check the Study Date Time of the exam on the image title bar, then they may interpret the current exam as a historical study and vice versa. The letter provided the users with safety instructions to follow until the software is updated. Direct any questions to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 847-277-5240.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 546 units
- Distribution
- Worldwide Distribution including USA and countries of Australia, Belgium, Brazil, Canada, Cayman Islands, Chile, Denmark, Ecuador, France, Germany, Hong Kong, Italy, Japan, Korea, Malaysia, Malta, Mex
- Date initiated
- 2008-09-25
- Date posted
- 2008-12-13
- Date terminated
- 2010-09-06
- 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 |