FDA recall Z-1930-2018

Product

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

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

Key facts

Status

Terminated

Initiation date

2018-02-21

Report date

2018-05-30

Termination date

2018-10-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hoffman Estates, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1930-2018