Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammog
FDA device recall Z-0118-2014 · posted 2013-10-30 · Terminated
Recall details
- Recalling firm
- Ge Healthcare It
- Reason for recall
- Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patients. These issues include: 1) With Auto-Fetch in use another patient's image may appear without user's intention. 2.a) In the case where dose administration time and image acquisition time fall on either side of midnight, the value will be under reported and close to zero for all pixe
- Action taken
- GE Healthcare sent an IMPORTANT PRODUCT INFORMATION letter dated June 15, 2012 to direct accounts informing them of the Auto-Fetch functionality issue and advising them to discontinue the use of the Auto-Fetch feature and to change the system setting to not allow users privileges to use Auto-Fetch. Customers were requested to contact their Field Engineer or GE Service Representative with any questions or to call the GE Healthcare Remote Online Center Customer Care Center at 1-800-437-1171. GE Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 12, 2013 to all affected customers informing them of all three of the safety issues. The letter again adivsed customers to discontinue the use of the Auto-Fetch feature and to change the system setting to not allow users privileges to use Auto-Fetch. The letter further infomed customers that all three errors can be resolved through the installation of a new version of the software. Customers were requested to contact their Field Engineer or GE Service Representative with any questions or to call the GE Healthcare Remote Online Center Customer Care Center at 1-800-437-1171.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 847 units
- Distribution
- Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, T
- Date initiated
- 2012-06-15
- Date posted
- 2013-10-30
- Date terminated
- 2016-06-10
- Location
- Barrington, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CENTRICITY PACS WEB DIAGNOSTIC (K083018) | Ge Healthcare Dynamic Imaging Solutions | 2008-11-14 |