# FDA recall Z-1057-2023

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

## Product

GE Nuclear Medicine 600/800 series systems, specifically:  a)	870 CZT O540+ Gantry 7.25mm,  b)	D670 CZT Gantry 7.25mm,  c)	DISCOV NM/CT 870 CZT,  d)	Discovery NMCT 670 CZT O540+,  e)	NM/CT 870 CZT CYBER DEFENCE,  f)	NM/CT 870 CZT O540,  g)	NM/CT 870 CZT WSO,  h)	NM/CT 870 CZT,  i)	NM/CT 870 CZT O540+ 7.25MM;  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-1057-2023
- **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-1057-2023

## Citation

> AI Analytics. FDA recall Z-1057-2023. Retrieved 2026-08-02 from https://api.ai-analytics.org/recall/Z-1057-2023. Source: US FDA. Licensed CC0.

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