Lightspeed 16 CT
FDA device recall Z-2801-2015 · posted 2015-09-21 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
- Action taken
- GE Healthcare sent an "Urgent Medical Device Correction" letter to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. Ref# 25463
- Root cause
- Process control
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 416
- Distribution
- Worldwide Distribution - US (nationwide) and to the countries of : ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, HUNGRY, INDIA, INDONESIA, ISRAEL,
- Date initiated
- 2015-07-17
- Date posted
- 2015-09-21
- Date terminated
- 2016-03-08
- 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 |
|---|---|---|
| MODIFICATION TO GE DISCOVERY LS SYSTEM (K040172) | GE Medical Systems | 2004-04-07 |
| LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM (K030420) | GE Medical Systems | 2003-03-10 |
| LIGHTSPEED 4.0 CT SCANNER SYSTEM (K013561) | GE Medical Systems | 2001-11-08 |