GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely
FDA device recall Z-1137-2013 · posted 2013-04-17 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. After starting the Results Viewer with the selected series of a patient, the pixel and certain annotation data from a different patient is displayed in one of the viewports. This occurs on an occasional basis, when multiple users are simultaneously accessing the Results Viewe
- Action taken
- GE Healthcare sent an "Important Product Information" letter dated June 27, 2012. The letter was addressed to Hospital Administrators , Radiology Managers and Risk Managers. The letter described the Subject, Instructions and Affected Product Details. GE Healthcare will correct all affected product by providing a software upgrade at no cost. For questions call: US 800-437-1171, Japan 0120-055-919, and/or local GE Healthcare Service Representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 429
- Distribution
- Worldwide Distribution - USA Nationwide including the states of: AK, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, LA, MD, MI, ,N, ,S, MO, MT, NJ, NM, NY, NC, OH, OK, PA, SC, SD, TN,TX, UT, VA, WA,
- Date initiated
- 2012-06-28
- Date posted
- 2013-04-17
- Date terminated
- 2014-02-04
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AW SERVER (K081985) | Ge Medical Systems, LLC | 2008-09-25 |