FDA Device Recall Z-1055-2023

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

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

Lot / serial / GTIN: 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;

Quantity: 7 units

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.

Recall record

Recall number: Z-1055-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: 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.
Recall initiated: 2022-12-19
Classified by FDA Center: 2023-02-08
FDA published: 2023-02-15
Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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