Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2033-2016·Announced 2016-06-29

Siemens Biograph mCT-S PET/CT scanners recalled for calibration error risk

Siemens is recalling 127 Biograph mCT-S PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

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 describes a potential for unexpected values without reporting any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Siemens Medical Solutions USA Inc. is recalling 127 units of the Biograph mCT-S(64) 4R, a combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanner. The recall is due to a potential for unexpected Standardized Uptake Value (SUV) readings if a non-Siemens phantom is used for the device's calibration.

The affected units were distributed worldwide and across the United States. The source text does not specify the exact number of patients affected or report any specific injuries or illnesses resulting from this issue.

Healthcare facilities should verify if they possess any of the affected serial numbers listed in the recall documentation. Siemens has identified the risk as related to the use of third-party calibration phantoms, which may compromise the accuracy of the scanner's quantitative measurements.

The recalled product

Product: Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 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: 127

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 (20)

Serial Numbers: 1013
11055
1005
1006
1004
1011
1003
1002
1008
1009
1010
11022
11028
1012
1016
1017
1019
11020
1007
11023

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 →

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