The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2185-2017·Announced 2017-06-21

GE Healthcare Optima CT520 X-ray system recalled for scan timing defect

GE Healthcare is recalling Optima CT520 X-ray systems because a defect may cause scans to start before a prescribed delay completes.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 functional defect that could lead to unintended radiation exposure or procedural errors, representing a risk of harm where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling the Optima CT520 X-ray system. The recall involves 10,884 units distributed worldwide, including the United States (nationwide and Puerto Rico) and numerous international locations.

The recall was initiated because an issue was identified that can result in a scan starting before the prescribed delay has completed. This defect affects the timing of the scanning process.

The source text does not specify specific actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with this defect.

The recalled product

Product
GE Healthcare Optima CT520 X-ray system
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment
Hazard
Affected units
10,884

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 (1)

  • n/a

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 16 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 16 products in this recall →

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