The Recall Desk
HighFDA (Devices)·Z-0369-2019·Announced 2018-11-21

GE Healthcare MyoSIGHT Nuclear Cardiology Imaging System Recall for Detaching Detector

GE Healthcare is recalling 276 Millennium MyoSIGHT Nuclear Cardiology Imaging Systems because a detector can detach and fall.

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: The recall involves a risk-of-harm product (falling detector) where injury has not yet been reported, which aligns with the High severity criteria for risk-of-harm products without reported injury.

Plain-English summary

GE Healthcare, LLC is recalling 276 units of the Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System. The recall was initiated because a detector on the system can detach and fall.

The affected systems were distributed to facilities in the United States, including all 50 states, the District of Columbia, Guam, and Puerto Rico, as well as to numerous international locations. The source text does not specify the exact number of units in each location or the specific dates of distribution.

No illnesses or injuries have been reported in the source text. Consumers and healthcare facilities should contact GE Healthcare for instructions on how to address the defect.

The recalled product

Product
GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging System
Hazard
Affected units
276

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 #: 0002910670AX
  • 0890013983
  • 0890079382
  • 201461MYO
  • 201858MYO
  • 202464MYO
  • 202741MYO
  • 203483MILL
  • 203688MYO
  • 203797NM13
  • 205739MC
  • 207641MYO
  • 209524MS
  • 209944MS
  • 212420MS
  • 212420MS1
  • 212535MS
  • 212777MS
  • 212870MS
  • 215624MYO

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 →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · falling object

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