Siemens Medical Solutions USA, Inc. recalls Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A sc
Recalled Product
Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Hazard / Issue
Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform sampling issue caused by a firmware change within the Universal Physiological Measurement Module.
Issued by
FDA
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