GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integrated IT Solutions, Barrington
FDA device recall Z-0928-2009 · posted 2009-01-27 · Terminated
Recall details
- Recalling firm
- GE Healthcare Integrated IT Solutions
- Reason for recall
- There is a potential patient safety issue involving patient jacket content, which may result in unintended historical image(s) being displayed.
- Action taken
- GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation software customers via letter (Urgent Medical Device Correction) dated 11/21/08 of the software anomaly resulting in a patient safety issue involving patient jacket content, which may result in unintended historical image(s) being displayed. The letter provided the users with safety instructions to follow until the software is updated. Please 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 414-918-4653.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 476 units
- Distribution
- Worldwide Distribution including USA and country of Canada.
- Date initiated
- 2008-11-21
- Date posted
- 2009-01-27
- 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 |