The Recall Desk
HighFDA (Devices)·Z-2584-2018·Announced 2018-08-08

GE Healthcare Recalls CT Systems With Potential Electrical Wiring Defect

GE Healthcare is recalling 42 Revolution EVO 3.6 CT systems installed with a specific electrical panel that may not be properly wired to the UPS.

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 electrical wiring defect that could compromise the Uninterruptible Power Supply. This is classified as a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

GE Healthcare, LLC is recalling 42 units of the Revolution EVO 3.6 CT and CT/PET systems. The recall involves 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 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 and system IDs for the affected units are listed in the official recall documentation.

Facilities with these systems should contact GE Healthcare to verify if their specific unit is affected and to arrange for the necessary corrective actions to ensure proper wiring to the UPS.

The recalled product

Product
Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — CT Scanner
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 (20)

  • a. HVY WAUK
  • Serial Number CJRBX1700130CN (System ID 770836EVO
  • UDI 01008406821097961117120021CJRBX1700130CN)
  • Serial Number CJRBX1800005CN (System ID 918635REVO
  • UDI 01008406821097961118010021CJRBX1800005CN)
  • b. LONG HINO
  • Serial Number RE36A1800042YC (System ID 864560REV1
  • UDI 01008406821097961118020021RE36A1800042YC)
  • Serial Number RE36A1800036YC (System ID 216448REVO
  • UDI 01008406821097961118020021RE36A1800036YC)
  • c. LONG WAUK
  • Serial Number CJRBX1800037CN (System ID 740383REVO
  • UDI 01008406821097961118040021CJRBX1800037CN)
  • Serial Number CJRBX1800022CN (System ID 317415REVO
  • UDI 01008406821097961118020021CJRBX1800022CN)
  • Serial Number CJRBX1800013CN (System ID 423844REVO
  • UDI 01008406821097961118010021CJRBX1800013CN)
  • Serial Number CJRBX1700132CN (System ID 719557REVO
  • UDI 01008406821097961117120021CJRBX1700132CN)
  • Serial Number CJRBX1800008CN (System ID 510248EVOCT

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

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Same hazard · electrical wiring defect

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