The Recall Desk
SevereFDA (Devices)·Z-2586-2018·Announced 2018-08-08

GE Healthcare Recalls Optima CT 540 Systems Due to Wiring Defect

GE Healthcare is recalling 42 Optima CT 540 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) per 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 540 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 serial number 500925HM3 and System ID Number 615320OPT.

This is a Class II recall, 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 for instructions on how to correct the wiring issue.

The recalled product

Product
Optima CT 540
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 (2)

  • Serial number 500925HM3
  • System ID Number 615320OPT

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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