[Recalled] Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information. — Possibility that the Biograph Horizon systems performing CT retros

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.