Home / Recalls / Philips Medical Systems (Cleveland) Inc / Z-1412-2018

Z-1412-2018 Class II Terminated

Recalled by Philips Medical Systems (Cleveland) Inc — Cleveland, OH

Recall Details

Product Type
Devices
Report Date
April 25, 2018
Initiation Date
February 8, 2018
Termination Date
April 9, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2

Product Description

Brilliance 16 Slice (Air) - Model no. 728246, 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.

Reason for Recall

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

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.

Code Information

Serial no: 50231 30019

Other recalls by Philips Medical Systems (Cleveland) Inc

  • Z-2570-2025 Class II — Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspac (August 5, 2025)
  • Z-2239-2025 Class II — Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software (July 17, 2025)
  • Z-1744-2022 Class II — Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237. (August 30, 2022)
  • Z-0215-2020 Class I — Forte Gamma Camera System is intended to produce images depicting the anatomical (September 19, 2019)
  • Z-0214-2020 Class I — Forte Gamma Camera System is intended to produce images depicting the anatomical (September 19, 2019)
  • Z-0213-2020 Class I — Forte Gamma Camera System is intended to produce images depicting the anatomical (September 19, 2019)
  • Z-0217-2020 Class I — Forte Gamma Camera System is intended to produce images depicting the anatomical (September 19, 2019)
  • Z-0216-2020 Class I — Forte Gamma Camera System is intended to produce images depicting the anatomical (September 19, 2019)
  • Z-2190-2019 Class II — iCT SP Model # 728311, computed tomography x-ray system (June 24, 2019)
  • Z-2189-2019 Class II — iCT, Model # 728306, computed tomography x-ray system (June 24, 2019)