GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This
Check against the official notice below — it lists the full affected range.
GE Healthcare has recalled 1,053 Revolution XR/d Digital Radiographic imaging systems and Proteus XR/a X-ray imaging systems due to a potential safety issue involving collimator installation errors that can occur during service maintenance activities. A collimator fall incident has been reported that caused serious patient injury. The affected systems have been distributed worldwide, including throughout the United States (all states except Vermont), Puerto Rico, DC, Guam, and numerous international countries.
The record does not specify what remedy consumers or healthcare facilities should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury.
Reason for recall: GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury. Distribution: Worldwide Distribution - USA including PR. DC, GUAM, all states except VT. Internationally to the following countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BENIN, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, BURKINA FASO, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, GUATE Quantity: 1053 Lot/code info: Mfg Lot or Serial # System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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.