GE Healthcare AW Server version 2.0 with release 2.0 - 4.0 A medical software system that allows multiple users to remot
FDA device recall Z-0486-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- 2 Unrelated Software Issues: An incorrect patient name maybe displayed when switching between two Volume Viewer tabs with different patients. Also, if a second patient exam is selected while the application is starting, the second patient's data will be displayed with the first patient's name display on the applications tab.
- Action taken
- Consignees were sent on 11/17/11 a GE "Urgent Medical Device Correction" letters dated November, 16 2011 The letter was addressed to Hospital Administrators, Radiology Mangers and Risk Managers. The letter described the Safety Issue, Safety Instructions Affected Product Details, Product Correction and Contact Information. For the first issue, customers were asked to contact their field engineer to install the correct configuration file. Also, customers should not apply the recommended changes from the Customer Release Note as those changes cause the issue to occur. With the second issue, customers are to wait until the application has fully initialized before making another patient exam selection. GE Healthcare will correct all affected AW server installations via a software upgrade at no cost to the customer. A representative will contact customers to arrange for the correction. Questions should be directed to customers' local GE Healthcare Service Representative or at the numbers provided in the letter.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 308
- Distribution
- Worldwide Distribution -- USA, including states of AZ, CA, CO, CT, DE, DC, FL, HI, IL, IN, LA, MD, MI, MN, MS,MO, NJ, NM, NY, NC, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, and WI and countries of UNITED
- Date initiated
- 2011-11-17
- Date posted
- 2012-01-11
- Date terminated
- 2012-07-03
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AW SERVER (K081985) | Ge Medical Systems, LLC | 2008-09-25 |