Z-1930-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 30, 2018
- Initiation Date
- February 21, 2018
- Termination Date
- October 12, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units
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.
Distribution Pattern
Domestic distribution to . International distribution to Finland, France, France, Iran, Ireland, Italy, Japan, Japan, Netherlands.
Code Information
Code No. 10532746, 10532748