The Recall Desk

FDA (Devices) recall action 64885

GE Healthcare, LLC recalled 2 products on 2013-05-08

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-05-08
Critical
0
Units
151

Why these products were recalled

Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··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.

    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.
    Category
    Distribution
    20 states
  • ModerateFDA (Devices)··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.

    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.
    Category
    Distribution
    20 states