The Recall Desk
HighFDA (Devices)·Z-2582-2018·Announced 2018-08-08

GE Healthcare Recalls Revolution CT 160 Systems Due to Wiring Defect

GE Healthcare is recalling 42 Revolution CT 160 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 involves a medical device with a potential safety hazard (improper UPS wiring) where no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

GE Healthcare, LLC is recalling 42 units of the Revolution CT 160 1.5D STD WAUK model. The recall is due to a potential defect where the systems may not be properly wired to the partial system uninterruptible power supply (UPS).

The affected units were distributed nationwide to facilities in 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 specific serial numbers involved are REVVX1800021CN and REVVX1800004CN.

Healthcare facilities should contact GE Healthcare to verify if their specific unit is affected and to arrange for the necessary wiring corrections.

The recalled product

Product
Revolution CT 160 1.5D STD WAUK
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 (4)

  • Model Number 5590000-6. Serial number REVVX1800021CN (System ID 812842REV
  • UDI 01008406821185521118020021REVVX1800021CN)
  • Serial Number REVVX1800004CN (System ID 269375REVOCT
  • UDI 01008406821185521118010021REVVX1800004CN).

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

See all →

Same hazard · electrical wiring

See all →