CLASS I ONGOING Device recall · Reported 15 Feb 2023 · FDA Enforcement Report

GE Nuclear Medicine 600/800 series systems, specifically recalled

Ge Medical Systems Israel, Functional Imaging is recalling GE Nuclear Medicine 600/800 series systems, specifically: a) Brivo B615 DHP BJG NR, b), distributed nationwide in the US. The recall was initiated on 19 Dec 2022 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesa) 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 recalled7 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1055-2023
FDA event ID: 91456
Recalling firm: Ge Medical Systems Israel, Functional Imaging, Tirat Carmel
Classification: Class I
Status: Ongoing
Recall initiated: 19 Dec 2022
FDA classified: 8 Feb 2023
Reported: 15 Feb 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

19 Dec 2022	Recall initiated by company
8 Feb 2023	Classified by FDA	+51 days
15 Feb 2023	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Puerto Rico

Questions about this recall

Is GE Nuclear Medicine 600/800 series systems, specifically: a) Brivo B615 DHP BJG NR, b) recalled?

Yes. Ge Medical Systems Israel, Functional Imaging recalled GE Nuclear Medicine 600/800 series systems, specifically: a) Brivo B615 DHP BJG NR, b) on 19 Dec 2022. The recall is Class I and its status is Ongoing. Recall number Z-1055-2023.

Why was it recalled?

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

Which lots are affected?

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;

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Ge Medical Systems Israel, Functional Imaging

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