Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System
FDA device recall Z-0105-06 · posted 2005-10-28 · Terminated
Recall details
- Recalling firm
- General Electric Med Systems LLC
- Reason for recall
- Cracked welds on the main rotation shaft could potentially lead to the collapse of the gantry yokes that support the detectors if the system is continued to be used after the weld has completely fractured.
- Action taken
- GE Healthcare issued an Urgent Safety Notice, dated 07/22/05, to all affected sites. This letter describes the potential hazard, its waring signs and the additional corrective actions that will be taken by GE Healthcare.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 140 (80 US and 60 OUS)
- Distribution
- Within the US to include: AL, AZ, CA, DE, FL, GA, IA, IL, KS, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TX, VA, WI and WV. OUS to include: Belgium, Brazil, Canada, China, Czech Republic, Egypt, France, Germ
- Date initiated
- 2005-09-27
- Date posted
- 2005-10-28
- Date terminated
- 2006-12-26
- 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 |
|---|---|---|
| DST-XL (K942837) | Sopha Medical Systems, Inc. | 1995-01-05 |