The Recall Desk
SevereFDA (Devices)·Z-2585-2018·Announced 2018-08-08

GE Healthcare Recalls Optima CT 520 Systems Due to Wiring Defect

GE Healthcare is recalling 42 Optima CT 520 units because they may not be properly wired to the uninterruptible power supply.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a severity score of 4 (Severe) according to the rubric, as it involves a defect that may cause temporary or medically reversible adverse health consequences.

Plain-English summary

GE Healthcare, LLC is recalling 42 units of the Optima CT 520 medical device. The recall was initiated because some of these systems, recently installed with a GE-supplied A! electrical panel, 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 unit identified in the recall notice has the serial number CBCRG1700051HM, System ID Number 580622O520, and UDI Number 01008406821025681117120021CBCRG1700051HM.

This recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Healthcare facilities should contact GE Healthcare to verify if their specific unit is affected and to arrange for necessary repairs or inspections.

The recalled product

Product
Optima CT 520
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)

  • Serial number
  • CBCRG1700051HM
  • System ID Number 580622O520
  • UDI Number 01008406821025681117120021CBCRG1700051HM

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 · electrical wiring defect

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