GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington
FDA device recall Z-0836-2009 · posted 2009-01-23 · Terminated
Recall details
- Recalling firm
- GE Healthcare Integrated IT Solutions
- Reason for recall
- There is a potential patient safety issue involving the use of the F12 keyboard Approve & Complete function. The issue may cause erroneous information to be added to a report when trying to approve and complete it.
- Action taken
- GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation software customers via letter (Urgent Medical Device Correction) dated 12/12/08 of the software anomaly resulting in a patient safety issue involving the use of the F12 keyboard Approve & Complete function. The issue may cause erroneous information to be added to a report when trying to approve and complete it. 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 414-918-4653.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 138 units
- Distribution
- Worldwide Distribution including USA and countries of Canada, China, Denmark, Germany, Hong Kong, India, Ireland, Italy, Japan, Korea, Lebanon, Mexico, Netherlands, Saudi Arabia, Spain, Taiwan and Uni
- Date initiated
- 2008-12-12
- Date posted
- 2009-01-23
- Date terminated
- 2010-05-18
- 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 |