Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2027-2016·Announced 2016-06-29

Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

Siemens is recalling 13 Biograph mCT Flow Edge-4R 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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

Siemens Medical Solutions USA Inc. is recalling 13 units of the BIOGRAPH mCT Flow Edge-4R, material number 10528955. These are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners used to provide registration and fusion of high-resolution physiologic and anatomic information.

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 affected units are identified by serial numbers 11001 through 11013 (specifically 11001, 11002, 11003, 11004, 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, and 11013).

The affected devices were distributed worldwide and nationwide in the United States. The source text does not specify the actions consumers or healthcare providers should take, nor does it report any illnesses or injuries associated with this recall.

The recalled product

Product: BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955 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: 13

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 (14)

Serial Numbers
11001
11002
11003
11004
11005
11006
11007
11008
11009
11011
11010
11013
11012

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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