GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington
FDA device recall Z-0970-2009 · posted 2009-02-03 · Terminated
Recall details
- Recalling firm
- GE Healthcare Integrated IT Solutions
- Reason for recall
- Unread exams may inadvertently get marked as dictated in PACS workstation when the user signs off the report in Talkstation and opens the next exam.
- Action taken
- GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation with Talk Extend software customers via letter (Urgent Medical Device Correction) dated 11/10/08 of the software anomaly resulting in a patient safety issue involving Talk Extend, which could contribute to a delay of care or misdiagnosis due to delay in communicating pertinent exam results or failure to treat due to lack of an attached dictated report by the radiologist for physician review. The letter provided the users with safety instructions to follow until the software is updated. Any questions were directed 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 847-939-1479.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 22 units
- Distribution
- California, Florida, Illinois, Iowa, Louisiana, Oregon, Pennsylvania, Texas, Utah, Virginia and Wisconsin.
- Date initiated
- 2008-11-20
- Date posted
- 2009-02-03
- 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 |