GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington
FDA device recall Z-0969-2009 · posted 2009-02-03 · Terminated
Recall details
- Recalling firm
- GE Healthcare Integrated IT Solutions
- Reason for recall
- If a user site created a custom default display protocol (DDP) to display the current exam versus the historical exam and the user-defined DDP fails, the system displays the exams using a GE default hanging protocol. This may create a potential for misdiagnosis if the user does not review the date and time stamps in the title bars.
- Action taken
- GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation software customers via letter (Urgent Medical Device Correction) dated 1/12/09 of the software anomaly resulting in a patient safety issue involving Default Display Protocols. The issue may create a potential for misdiagnosis if the user does not review the date and time stamps in the title bars. 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
- 778 units
- Distribution
- Nationwide, Canada, Bermuda, Mexico, Ecuador, Chile, and Brazil
- Date initiated
- 2009-01-12
- Date posted
- 2009-02-03
- 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 |