—#164356

Product

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

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K170904
Affected lot / code info: Code No. 10532746, 10532748

Why it was recalled

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.

Root cause (FDA determination)

Software design (manufacturing process)

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 2501 Barrington Rd, Hoffman Estates, Illinois 60192-2061

Distribution

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

Timeline

Recall initiated: 2018-02-21
Terminated: 2018-10-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #164356. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.