medical Class II Updated 2018-05-30

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

Distribution: Domestic distribution to . International distribution to Finland, France, France, Iran, Ireland, Italy, Japan, Japan, Netherlands.
Lot/Code Info: Code No. 10532746, 10532748
View official government recall

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