GE Centricity PACS RA1000 Workstation software (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, B
FDA device recall Z-1543-2009 · posted 2009-07-13 · Terminated
Recall details
- Recalling firm
- GE Healthcare Integrated IT Solutions
- Reason for recall
- Software anomalies may allow the image orientation to be misinterpreted, posing a potential patient safety issue.
- Action taken
- GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation Software Versions 2.1.x and 3.0.x customers via an Urgent Medical Device Correction notice dated March 2, 2009 of the affected device resulting in patient safety issues. The letter provided users with safety instructions until the software is updated. Consignees are requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 1-847-939-1479. Centricity PACS RA1000 Workstation Software Versions PathSpeed 7.x, 8.x, Centricity 1.X and 2.0.X customers were sent separate letters explaining the recall including instructions. There will be no software updates since those software versions are no longer being supported. For questions, call the Remote Online Center, Field Engineer or the GE Customer Care Center at 1-800-437-1171.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 984 units
- Distribution
- Worldwide Distribution - US including Puerto Rico and countries of Brazil, Canada, Chile, Ecuador, Mexico, Australia, China, Hong Kong, Japan, Korea, Malaysia, New Zealand, Singapore, Taiwan, Austria,
- Date initiated
- 2009-03-24
- Date posted
- 2009-07-13
- 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 |