# FDA recall Z-1058-2023

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

## Product

GE Nuclear Medicine 600/800 series systems, specifically: a)	850,  b)	850 / Dismount,  c)	850 3/8 inch NM Gantry,  d)	860 / Dismount,  e)	860 3/8 inch NM Gantry,  f)	860 5/8 inch NM Gantry,  g)	860 BJ,  h)	NM 830 3/8 inch BJ,  i)	NM/CT 850 3/8 inch BJ,  j)	NM/CT 850 3/8 inch ROW,  k)	NM/CT 850 3/8 inch ROW_,  l)	NM/CT 850 CT 850 3/8 inch,  m)	NM/CT 850 ES 3/8 inch,  n)	NM/CT 850 ES 3/8 inch ROW,  o)	NM/CT 860 3/8 inch,  p)	NM/CT 860 3/8 inch BJ,  q)	NM/CT 860 3/8 inch ROW,  r)	NM/CT 860 ADVANCE,  s)	NM/CT 860 advance 3/8 inch NM Gantry,  t)	NM/CT 860 BEYOND,  u)	NM/CT 860 beyond 3/8 inch NM Gantry,  v)	NM/CT 860 China for China,  w)	NM/CT 860 CT 860 3/8 inch,  x)	NM/CT 860 ES 3/8 inch,  y)	NM/CT 860 ES 3/8 inch ROW,  z)	NM/CT 850 3/8 inch,  aa)	NM/CT 850 ES 3/8 inch ROW,  bb)	NM/CT 860 3/8 inch CH,  cc)	XELERIS 4 DR WORKSTATION;    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-1058-2023
- **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-1058-2023

## Citation

> AI Analytics. FDA recall Z-1058-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1058-2023. Source: US FDA. Licensed CC0.

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