Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 5/30/2018
Class II:
PRODUCT
Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system Recall Number: Z-1930-2018
REASON
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.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Hoffman Estates, IL on 2/21/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
Nationwide and Internationally