The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2186-2017·Announced 2017-06-21

GE Healthcare Optima CT540 X-ray System Recalled for Scan Timing Issue

GE Healthcare is recalling 10,884 Optima CT540 X-ray systems because a software issue 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 where a functional defect (scan timing) poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

GE Healthcare, LLC is recalling 10,884 units of the Optima CT540 X-ray system. The recall was initiated after it was discovered that an issue can result in a scan starting before the prescribed delay has completed.

The affected units were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in numerous other countries. The source text does not specify a particular lot number or date of manufacture.

Consumers and healthcare facilities should contact GE Healthcare for instructions on how to address this issue. The source text does not provide specific contact details or remediation steps.

The recalled product

Product
GE Healthcare Optima CT540 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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