Recall Z-1930-2018— Siemens Medical Solutions USA, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2018-02-21, terminated 2018-10-12. It names one FDA 510(k) clearance: K170904. Product: Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.. 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
- Siemens Medical Solutions USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-21
- Terminated
- 2018-10-12
- Firm location
- Hoffman Estates, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.