Is GE Healthcare Revolution EVO X-ray system recalled?

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. Status: FDA Mandated Initial Firm Notification: Letter Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

Medium RiskFDA Device

GE Healthcare, LLC: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Agency Publication Date: June 12, 2017

Affected Products

Product: GE Healthcare Revolution EVO X-ray system

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Product: GE Healthcare Optima CT660, CT680 X-ray system

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Product: GE Healthcare LightSpeed VCT X-ray system

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Product: GE Healthcare Optima CT580; Discovery RT, CT590 RT X-ray system

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Product: GE Healthcare Optima CT520 X-ray system

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Product: GE Healthcare Optima CT540 X-ray system

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Product: GE Healthcare lnnova IGS 540 ACT X-ray system

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Product: GE Healthcare BrightSpeed X-ray system

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Product: GE Healthcare Lightspeed RT16 X-ray system

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Product: GE Healthcare Discovery PET/CT 600,610, 690, 710: Optima PET/CT 560. 560FX X-ray system

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Product: GE Healthcare Discovery Ml DR X-ray system

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Product: GE Healthcare Discovery IQ X-ray system

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Product: GE Healthcare Discovery Ml X-ray system

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Product: GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system

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Product: GE Healthcare Discovery NM/CT 670 CZT X-ray system

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Product: GE Healthcare Discovery NM/CT 570c X-ray system

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77377

Status: Resolved

Manufacturer: GE Healthcare, LLC

Manufactured In: United States

Units Affected: 16 products (10,884)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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