The Recall Desk
HighFDA (Devices)·Z-2579-2018·Announced 2018-08-08

GE Healthcare Recalls Digital Ready CT/PET Systems Due to Wiring Defect

GE Healthcare is recalling 42 Discovery MI Digital Ready CT/PET systems because they may not be properly wired to the uninterruptible power supply.

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 is classified as FDA Class II, which typically indicates a risk of temporary or medically reversible health consequences. The hazard is a wiring defect that could affect power supply, but no injuries or illnesses have been reported.

Plain-English summary

GE Healthcare, LLC is recalling 42 units of the Discovery MI Digital Ready CT/PET system. The recall is due to a potential wiring defect in systems recently installed with a GE-supplied A! electrical panel. These systems may not be properly wired to the partial system uninterruptible power supply (UPS).

The affected units were distributed nationwide to Alabama, California, Colorado, Florida, Illinois, Indiana, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas, and Virginia. The recall is classified as Class II by the FDA.

Healthcare facilities should contact GE Healthcare for instructions on how to correct the wiring issue. Consumers are not directly affected by this recall, as the product is a medical device used in clinical settings.

The recalled product

Product
Discovery MI Digital Ready
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment
Hazard
Affected units
42

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 (8)

  • Model Number 5986030. a. Serial Number PTDMI1800003PT
  • System ID Number RADNETPT1839
  • UDI Number 01008406821209751118010421PTDMI1800003PT
  • b. Serial Number PTDMI1800005PT
  • System ID Number RADNETPT1838
  • c. Serial Number PTDMI1800009PT
  • System ID Number 813745DMIDR2
  • UDI Number 01008406821209751118021921PTDMI1800009PT

Distribution

Distributed nationwide across the United States.

The notice also names 19 states specifically:

Part of a larger recall action

This product is one of 10 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 10 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · wiring defect

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