# FDA recall Z-1055-2023

> **GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING** · Class I · device recall initiated 2022-12-19.

## 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;    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

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.

## Key facts

- **Recall number:** Z-1055-2023
- **Recalling firm:** GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-19
- **Report date:** 2023-02-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tirat Carmel, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1055-2023

## Citation

> AI Analytics. FDA recall Z-1055-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1055-2023. Source: US FDA. Licensed CC0.

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