Device product
Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Z-1409-2018
Product summary
- Event
- Event 79666
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19
- Official record key
device-enforcement:Z-1409-2018
Official wording
Reason: Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Code information: Serial No : 200205 200203 200210 200213 200208 200204 200212 200201 200206 200207 200209 200215 83001 200200 200202 200200 200043 200211 200214
Distribution pattern: Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.
Derived failure modes
-
Unknown
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.