AdvantageSim MD versions 7.4 through 7.6, Model 5160092. AdvantageSim MD is used to prepare geometric and anatomical dat
FDA device recall Z-1718-2009 · posted 2009-08-17 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- It was reported by a customer site that when using Advantage Sim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated.
- Action taken
- GE Healthcare issued an "Urgent Medical Device Correction" letter dated March 11, 2009. The letter was addressed to AdvantageSim Customers, Hospital Administrators/ Risk Mangers and Oncology Department Mangers. The letter addressed the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. For further questions, contact GE Healthcare at 1-800-437-1171 (US), 0120-055-919 (Japan) and for other countries, contact your local GE Healthcare sales or field service representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPQ
- Quantity affected
- 687 units (351 US / 336 OUS)
- Distribution
- Worldwide Distribution -- Including states of AL, AZ, CA, CO, CT, FL, GA, DC, ID, IL, IN, IA, KS, LA, ME, MD, MA, MI, MN, MS,MO, MT,NE, NH, NJ, NM, NY, NC, ND, OH, OK PR, PA, SC, SD, TN, TX, UT, VA, W
- Date initiated
- 2009-02-02
- Date posted
- 2009-08-17
- Date terminated
- 2011-12-10
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVANTAGE SIM MD (K052345) | GE Healthcare | 2005-09-14 |