GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) pr
FDA device recall Z-0265-2008 · posted 2007-11-28 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Aortic Length over-estimated: incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed the aorta analysis protocol or the customized protocols for an aneurysm should NOT BE USED.
- Action taken
- An Urgent Safety Notice to customers dated 9/10/07, was issued by the recalling firm informing them of the device defect, safety issues, warnings on future uses and promised new software updates to be installed by GE representatives, free of charge, beginning Nov. 2007.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 2,518
- Distribution
- Worldwide Distribution - USA including states of AK, AL, AR, AZ, CA, CO, CT, CU, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR,
- Date initiated
- 2007-09-10
- Date posted
- 2007-11-28
- Date terminated
- 2011-12-17
- 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 WORKSTATION 4.3. (K052995) | GE Healthcare | 2005-11-08 |
| ADVANTAGE WORKSTATION 4.1 (K020483) | GE Medical Systems | 2002-02-28 |