# FDA recall Z-1054-2023

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

## Product

GE Nuclear Medicine 600/800 series systems, specifically:  a)	830,  b)	830  / Dismount,  c)	830 /,  d)	830 / 5842894-20,  e)	830 / Dismount / 50HZ,  f)	830 / Dismount / 60HZ,  g)	830 3/8 inch Detector,  h)	830 BJ,  i)	830 BJ / 5144407,  j)	830 BJ / Dismount,  k)	830 ES DEM,  l)	830 NM Cyber Defense Configuration Gantry 3/8 inch,  m)	830 NM Gantry 3/8 inch,  n)	830 NM Gantry 5/8 inch,  o)	870 DR NM GANTRY FINAL - NEW ROTOR,  p)	B615 to D630 UPG,  q)	D630 NM GANTRY,  r)	D630 NM GANTRY 3/8 inch WITH NEW ROTOR - MEA,  s)	D630 NM Gantry 3/8 inch,  t)	D630 NM GANTRY FINAL ASSEMBLY_,  u)	D630 with new rotor,  v)	D630 with new rotor/ 5144407 / Dismount,  w)	D630 with new rotor/ Dismount,  x)	DISCOVERY  D630 X 3/8 inch,  y)	DISCOVERY D630 X 3/8 inch,  z)	DISCOVERY D630 X 3/8 inch,  aa)	DISCOVERY D630 x 3/8 inch BHW,  bb) 	DISCOVERY D630 X 3/8 inch BJG,  cc)	DISCOVERY D630 X 3/8 inch MEA,  dd) 	DISCOVERY NM 830 3/8 inch,  ee)	DISCOVERY NM 830 3/8 inch,  ff)	NM 830 3/8 inch,  gg)	NM 830 3/8 inch 

## 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-1054-2023
- **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-1054-2023

## Citation

> AI Analytics. FDA recall Z-1054-2023. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-1054-2023. Source: US FDA. Licensed CC0.

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