GE Nuclear Medicine BRIVO B615 Imaging System Detector Fall Risk
GE Nuclear Medicine BRIVO B615 imaging systems may have an ineffective safety mitigation, allowing the detector to fall and cause life-threatening injury. The FDA issued a Class I recall for seven units distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4 per the rubric. Although no injuries have been reported, the potential for life-threatening bodily injury from detector failure in medical imaging equipment justifies this rating.
Plain-English summary
GE Medical Systems Israel has recalled seven units of the GE Nuclear Medicine 600/800 series systems, specifically the BRIVO B615 Emission Computed Tomography imaging systems. These are diagnostic medical devices used in nuclear medicine imaging procedures.
The recalled devices have a safety mitigation that may not be correctly implemented. If the mitigation fails, the detector component can fall, creating a risk of life-threatening bodily injury to patients and medical staff.
The seven affected units have been distributed worldwide, including throughout the United States (including Puerto Rico) and to more than 80 additional countries and territories. The FDA has classified this as a Class I recall due to the serious safety hazard posed by detector failure.
The recalled product
- Product
- 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; Emissio
- Manufacturer
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Hazard
- falling-detector
- injury-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- 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
- Serial Numbers: NT2QG2000001BH
- d) B615 with new rotor: Catalog number 5376204-16
- Serial Numbers: NT2QG1900002BH
- e) BRIVO B615 3/8 inch BJG: Catalog number 5376204-16
- Serial Numbers: NT2QG1800001BH
- f) BRIVO B615 3/8 inch DHP BJG NR: Catalog number H2402MP
- Serial Numbers: 00000168527HL0
- g) B615 with new rotor: Catalog number To be provided
- Serial Numbers: NT2QG2000003BH
Distribution
Distributed nationwide across the United States.
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