Siemens recalls Biograph Horizon PET/CT systems with VJ10A, VJ10B, VJ20A scanners due to potential waveform sampling issues during cardiac gating exams. Affected units may require firmware updates.
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.
Siemens is recalling certain Biograph Horizon PET/CT systems that use VJ10A, VJ10B, or VJ20A scanners. The recall is due to a possible waveform sampling issue that could affect cardiac gating exams, though the risk is not severe enough to require immediate stoppage.
The firmware change in the Universal Physiological Measurement Module could cause waveform sampling issues during CT retrospective cardiac gating or PET cardiac gating exams. This might lead to inaccurate imaging results but does not pose a direct safety risk to patients or staff.
Medical facilities using the recalled Biograph Horizon systems with specific scanner models are affected. Patients undergoing cardiac imaging with these systems may be at low risk.
Check if your scanner model is VJ10A, VJ10B, or VJ20A. The recall covers specific Siemens Biograph Horizon PET/CT systems with code numbers 10532746 and 10532748.
Identify if your scanner uses VJ10A, VJ10B, or VJ20A models.
No, the recall does not require immediate stoppage. The issue is a potential waveform sampling problem during cardiac imaging, not a safety hazard.
The recall does not specify a remedy, so no action is required. Contact Siemens for further guidance if you have concerns.
The recall states there is no risk of serious injury, so patients are not at immediate danger.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1930-2018 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1930-2018 from Siemens. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
