Home / Recalls / Siemens Medical Solutions USA, Inc. / Z-1930-2018

Z-1930-2018 Class II Terminated

Recalled by Siemens Medical Solutions USA, Inc. — Hoffman Estates, IL

FDA device recall Z-1930-2018 was initiated by Siemens Medical Solutions USA, Inc. on Feb 21, 2018 and is designated Class II. 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 recall status is terminated (terminated Oct 12, 2018). Affected quantity: 14 units.

Recall Details

Product Type: Devices
Report Date: May 30, 2018
Initiation Date: Feb 21, 2018
Termination Date: Oct 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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1930-2018
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.