Siemens Biograph Horizon PET/CT Systems Recalled for Firmware Issue
Siemens Medical Solutions is recalling 14 Biograph Horizon PET/CT systems due to a firmware issue that may cause waveform sampling errors during cardiac gating examinations.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, a Class II recall without reported hospitalizations or injuries falls under the 'High' category, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 14 units of the Biograph Horizon PET/CT System. The affected systems utilize VJ10A, VJ10B, or VJ20A scanners and are identified by Code No. 10532746 or 10532748.
The recall is issued because of a possibility that the systems may experience a waveform sampling issue. This issue is caused by a firmware change within the Universal Physiological Measurement Module and may affect examinations performing CT retrospective cardiac gating or PET cardiac gating.
The affected units were distributed domestically and internationally to Finland, France, Iran, Ireland, Italy, Japan, and the Netherlands. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the firmware issue.
The recalled product
- Product
- Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 14
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Code No. 10532746
- 10532748
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc.
See all →- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · firmware defect
See all →- HighParagonix KidneyVault Portable Renal Perfusion System Recalled for Firmware Defect
FDA (Devices) · 2026-08-26
- HighPhilips Allura Xper FD Fluoroscopic X-Ray System Recalled for Firmware Issue
FDA (Devices) · 2026-08-19
- HighPermobil M3 Corpus Power Wheelchair Recalled Over Firmware Stability Issue
FDA (Devices) · 2026-08-05
- HighiLet Bionic Pancreas pumps may become stuck on the lock screen
FDA (Devices) · 2026-06-24
- HighNatus SD LTM 64 PLUS EEG recorders may shift traces one second
FDA (Devices) · 2026-06-17