The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1211-2013·Announced 2013-05-08

GE Healthcare Recalls MSK Extreme MR Scanners Due to Coolant Leak Risk

GE Healthcare is recalling 70 MSK Extreme MR Scanners because coolant supply lines may leak liquid onto the floor, creating a slippery surface and fall hazard.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

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 potential fall risk from a slippery surface without reported injuries or deaths, fitting the criteria for a moderate severity recall.

Plain-English summary

GE Healthcare, LLC is recalling 70 units of the MSK Extreme MR Scanner, Model AA5000. These diagnostic imaging devices are intended to produce images of the internal structures of the leg, knee, ankle, foot, forearm, elbow, wrist, and hand.

The recall is being conducted 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 the safety of the equipment.

The recalled product

Product
MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
70

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)

  • 01072011-001
  • 01082010-001
  • 01182010-001
  • 01182011-001
  • 01272010-001
  • 02032011-001
  • 02112010-001
  • 02182011-001
  • 02242010-001
  • 2262011-001
  • 03012010-001
  • 03072010-001
  • 03132009-001
  • 03242009-001
  • 03292011-001
  • 03302011-001
  • 04012010-001
  • 04082010-001
  • 04192011-001
  • 04202011-001

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

See all →

Same hazard · slippery surface

See all →

Similar recalls