The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0370-2019·Announced 2018-11-21

GE Healthcare Recalls Gamma Camera Systems Due to Falling Detector Risk

GE Healthcare is recalling 1,166 Millennium MG gamma camera systems because a detector can detach and fall.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "A detector can detach and fall."

Plain-English summary

GE Healthcare, LLC is recalling 1,166 units of the Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System. The recall is due to a safety hazard where a detector can detach and fall.

The affected systems were distributed across all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico, as well as numerous international locations including Canada, the United Kingdom, Germany, and Japan. The source text does not specify the exact number of reported injuries or illnesses associated with this defect.

Healthcare facilities should contact GE Healthcare for instructions on how to address the defect. Consumers and patients should be aware that the equipment may pose a physical hazard if a component falls.

The recalled product

Product
GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment
Hazard
Affected units
1,166

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 (20)

  • System ID #: 334428MG
  • 256235NM2
  • 251660KWMG
  • 251410IMCMG
  • 501776MG
  • 870836MG
  • 870364MG
  • 479443MG1
  • 870261MG
  • 501520MG
  • 501614MC
  • 501224MC
  • 501686MG
  • 501202WMG
  • 870541MG
  • 501380MG
  • 479751MG
  • 501484MG
  • 479314MG2
  • 501474MG

Distribution

Distributed in 50 states:

Part of a larger recall action

This product is one of 3 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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