Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
- Recall Initiated
- February 21, 2018
- Terminated
- October 12, 2018
- Recall Number
- Z-1930-2018
- Quantity
- 14 units
- Firm Location
- Hoffman Estates, IL
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
Domestic distribution to . International distribution to Finland, France, France, Iran, Ireland, Italy, Japan, Japan, Netherlands.
Lot / Code Info
Code No. 10532746, 10532748
Root Cause
Software design (manufacturing process)
Action Taken
Customers were notified via letter on approximately 02/21/2018. Letters were sent via certified mail or email. Instructions included to discontinue use of the system (according to the cardiac imaging protocols listed in the letter), ensure the customer advisory notice is placed in the Biograph Horizon Operator's Manual, ensure the recall information is disseminated to all operators of the system, coordinate the installation of the updated Universal Physiological Measurement Module with Siemens Healthineers, and if the equipment has been sold to forward the letter to the new owner.