Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1425-2017·Announced 2017-03-15

Siemens Biograph Mobile PET/CT Recall for Missing Instructions

Siemens is recalling four Biograph Mobile PET/CT units because specific mobile instructions were not shipped to a limited population.

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 hazard is a documentation issue (missing instructions) rather than a direct physical defect or contamination, fitting the Moderate criteria for minor labeling or documentation errors.

Plain-English summary

Siemens Medical Solutions USA Inc. is recalling four units of the Biograph 16 TruePoint TrueV - 4R Mobile PET/CT system. The recall is due to the fact that mobile-specific instructions were not shipped to a limited population of these systems.

The affected units were distributed worldwide, including in the United States and in Switzerland, Great Britain, and Italy. The specific serial numbers for the affected units are 72484, 72490, 72516, and 72536.

Healthcare professionals should contact Siemens Medical Solutions USA Inc. to obtain the missing instructions and ensure the devices are used in accordance with the intended instructions for use.

The recalled product

Product: Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the…
Manufacturer: Siemens Medical Solutions USA Inc.
Category: Medical Device — Imaging Equipment
Hazard: missing-instructions
Affected units: 4

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 (4)

72484
72490
72516
72536

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · Siemens Medical Solutions USA Inc.

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