FDA-Device2018-05-30Class II
Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Siemens Medical Solutions USA, Inc.
Hazard
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.
Sold states
Domestic distribution to . International distribution to Finland, France, France, Iran, Ireland, Italy, Japan, Japan, Netherlands.
Affected count
14 units
Manufactured in
2501 Barrington Rd, N/A, Hoffman Estates, IL, United States
Products
Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1930-2018Don't want to check this manually?
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