The Recall Desk
ModerateFDA (Devices)·Z-1212-2013·Announced 2013-05-08

GE Healthcare Recalls Optima MR430s MRI Scanners Due to Coolant Leak Risk

GE Healthcare is recalling 81 Optima MR430s MRI scanners because coolant supply lines may leak liquid onto the floor, creating a slippery surface and fall hazard.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a fall risk from a slippery surface without reported injuries or fatalities, fitting the criteria for a moderate severity level.

Plain-English summary

GE Healthcare, LLC is recalling 81 units of the Optima MR430s MRI Scanner. The device is indicated for use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand.

The recall is being issued because the coolant supply lines may leak liquid onto the floor. This leakage can result in a slippery surface, creating a fall hazard for individuals in the area.

The affected units were distributed worldwide, including in the United States and various international locations. Consumers and healthcare facilities should contact GE Healthcare for instructions on how to address the potential leak and ensure safety.

The recalled product

Product
Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — MRI Scanner
Hazard
Affected units
81

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)

  • 08022011-001
  • 09092011-001
  • 12102011-001
  • 05152012-004
  • SM11062012-001
  • 02022012-001
  • 08142012-001
  • 04212012-001
  • 05252012-002
  • 12132011-001
  • SM08292012-007
  • 11052011-002
  • 01192012-001
  • 01132012-001
  • 06282012-010
  • 07252012-001
  • 01022012-001
  • 11202011-001
  • 08142011-001
  • 06302011-001

Distribution

Distributed in 20 states:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · slippery surface

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