Siemens Medical Solutions USA, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1930-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Product Classification:

Class II

Date Initiated: February 21, 2018

Date Posted: May 30, 2018

Recall Number: Z-1930-2018

Event ID: 80071

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.

Status: Terminated

Product Quantity: 14 units

Code Information:

Code No. 10532746, 10532748

Distribution Pattern:

Domestic distribution to . International distribution to Finland, France, France, Iran, Ireland, Italy, Japan, Japan, Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated