Z-1055-2023 Class I Ongoing
Recalled by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
— Tirat Carmel
Recall Details
- Product Type
- Devices
- Report Date
- February 15, 2023
- Initiation Date
- December 19, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
Product Description
GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; Emission Computed Tomography System
Reason for Recall
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Distribution Pattern
Worldwide distribution. US nationwide including Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Ethiopia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uzbekistan, and Vietnam.
Code Information
a) BRIVO B615 3/8 inch DHP BJG NR: Catalog number 5376204-16, UDI/DI Not Applicable, Serial Numbers: NT2QG1900001BH; b) BRIVO 615 3/8 inch: Catalog number 5376204-16, UDI/DI To be provided, Serial Numbers: NT2QG2000002BH; c) BRIVO B615 3/8 inch DHP BJG NR: Catalog number 5376204-16, UDI/DI Not Applicable, Serial Numbers: NT2QG2000001BH; d) B615 with new rotor: Catalog number 5376204-16, UDI/DI To be provided, Serial Numbers: NT2QG1900002BH; e) BRIVO B615 3/8 inch BJG: Catalog number 5376204-16, UDI/DI Not Applicable, Serial Numbers: NT2QG1800001BH; f) BRIVO B615 3/8 inch DHP BJG NR: Catalog number H2402MP, UDI/DI To be provided, Serial Numbers: 00000168527HL0; g) B615 with new rotor: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT2QG2000003BH;