Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2019-2016·Announced 2016-06-29

Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

Siemens is recalling two Biograph PET/CT scanners due to a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential for incorrect calibration values, which fits the criteria for a moderate severity recall involving a risk of harm where injury has not yet been reported or a precautionary measure.

Plain-English summary

Siemens Medical Solutions USA Inc. is recalling two units of the Biograph TruePoint combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners. The affected units are identified by serial numbers 1007 and 1008, with material number 10246389. These systems were distributed worldwide and across the United States.

The recall was initiated because Siemens Medical Solutions, Molecular Imaging became aware of a potential for unexpected Standardized Uptake Value (SUV) values if a non-Siemens phantom is used for calibration. The source text does not report any specific injuries, illnesses, or deaths associated with this issue.

Facilities using these scanners should contact Siemens Medical Solutions USA Inc. for further instructions on how to address the calibration risk. The source text does not provide specific consumer action steps beyond the general recall notification.

The recalled product

Product: BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Manufacturer: Siemens Medical Solutions USA Inc.
Category: Medical Device — Imaging Equipment
Hazard: calibration-error
Affected units: 2

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)

Serial Numbers: 1007
1008

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 33 recalled by Siemens Medical Solutions USA Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 33 products in this recall →

Same manufacturer · Siemens Medical Solutions USA Inc.

See all →

Moderate
ARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
High
ARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
Moderate
ARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
High
ARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
High
ARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10

Same hazard · calibration error