The Recall Desk
HighFDA (Devices)·Z-0371-2019·Announced 2018-11-21

GE Healthcare Millennium MC Medical Device Recall for Detachment Risk

GE Healthcare is recalling 18 Millennium MC units 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 object) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

GE Healthcare, LLC is recalling 18 units of the GE Healthcare Millennium MC medical device. The recall is due to a safety hazard where a detector can detach and fall.

The affected devices were distributed to various locations in the United States, including Alaska, Alabama, and California, as well as numerous international locations such as Canada, Germany, and Japan. Specific System ID numbers for the affected units are listed in the official recall documentation.

Consumers and healthcare facilities should contact GE Healthcare for further instructions on how to address this issue. The source text does not provide specific dates or additional details on the distribution scope beyond the listed regions.

The recalled product

Product
GE Healthcare Millennium MC
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment
Hazard
Affected units
18

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 (18)

  • System ID #: 870735MG
  • 928333WMM02
  • 970635MYO
  • 203576DNT
  • 407896FMG2
  • 954634MG
  • 316267KCN
  • 601883NMC2
  • 910483XEL1
  • 910296MMG
  • 908277XL2
  • 908277MG2
  • 908218MYO
  • 918496EN1
  • 972759CROWNMG
  • 940566MG
  • 972434MC
  • and 972473MYO.

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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