GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. Device that receives, store
FDA device recall Z-1402-2010 · posted 2010-04-16 · Terminated
Recall details
- Recalling firm
- Ge Healthcare It
- Reason for recall
- There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software when dragging-and-dropping images from the Navigator causing flipping of the images that may impact patient safety.
- Action taken
- GE Healthcare issued "Urgent Medical Device Correction" notifications dated February 11, 2010. The initial notification advised users of the patient safety issues associated with the affected product. Separate letters provided the users with specific safety instructions. 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. For additional information, contact the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171.
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 29 units
- Distribution
- Worldwide Distribution -- United States (California, Illinois, Indiana, Minnesota, Nevada, New York and Wisconsin), Austria, Canada, Finland, France, Germany, Ireland, Lebanon, Japan, Philippines, Sau
- Date initiated
- 2010-02-11
- Date posted
- 2010-04-16
- Date terminated
- 2010-11-15
- Location
- Barrington, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CENTRICITY PACS IW (K082318) | Ge Healthcare Dynamic Imaging Solutions | 2008-08-25 |