The Recall Desk
HighFDA (Devices)·Z-0895-2025·Announced 2025-01-22

GE Healthcare Discovery NM/CT 670 Systems Risk of Detector Fall During Transport

GE Healthcare's Discovery NM/CT 670 nuclear medicine imaging systems may have detectors that fall if not properly supported during transport or relocation, posing risk of life-threatening injury.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with potential for life-threatening injury if detectors fall. However, no incidents, illnesses, or hospitalizations have been reported. The hazard is conditional and theoretical rather than confirmed.

Plain-English summary

GE Healthcare is recalling eight Discovery NM/CT 670 nuclear medicine imaging systems (model H3906AB) distributed worldwide. These systems could experience detector falls if they were transported or relocated without proper detector support during handling.

The detector mounting mechanisms in these systems were designed to operate with adequate support. If systems were moved or transported without maintaining proper detector support, excessive load can be applied to the mounting mechanisms. This could result in detector failure and a detector fall, creating a risk of life-threatening bodily injury to personnel.

If you operate one of the affected systems, contact GE Healthcare immediately for assistance and guidance regarding your system.

The recalled product

Product
GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission
Manufacturer
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Category
Medical Device — Nuclear Medicine Imaging Equipment
Hazard
  • detector-fall
  • injury-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

  • 1) H3906AB: UDI/DI 840682121446
  • System ID UX2305NU03
  • Serial Number CZTV29005
  • UDI/DI 840682121446
  • System ID M4166103
  • Serial Number CZTV29006
  • System ID 00243NUC22
  • Serial Number CZTW29008
  • System ID 00222NUC07
  • Serial Number CZTW29009
  • UDI/DI N/A
  • System ID 604875D670B
  • Serial Number CZTW29007
  • System ID NT6200
  • Serial Number AD7W38007
  • System ID NT6201
  • Serial Number AD7X38017
  • System ID NT6100
  • Serial Number AP7W37001.

Distribution

Distribution scope not specified by the agency.

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