Agency classClass IIOur severity:High FDA (Devices)·Z-1337-2020·Announced 2020-02-26

Siemens Luminos dRF Max Recalled for Software Bug Affecting Patient Images

Siemens Medical Solutions USA, Inc. is recalling 46 Luminos dRF Max digital radiography systems due to a software bug that may assign one image to two different patients, potentially affecting medical diagnosis.

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 3/5 (High).

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. The hazard involves a risk of harm to patients through potential misdiagnosis due to image misassignment, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 46 units of the Luminos dRF Max digital radiography system, model number 10762471. The device is intended to visualize anatomical structures by converting an X-ray pattern into a visible image for various medical examinations, including gastrointestinal, cranial, skeletal, thoracic, lung, and urogenital tract studies.

The recall is due to a software bug that may lead to one image being assigned to two different patients. This error could potentially affect medical diagnosis. The affected units were distributed nationwide in the United States.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the software issue. The specific serial numbers of the affected units are listed in the official recall documentation.

The recalled product

Product: Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Imaging Equipment
Hazard: software-bug
misdiagnosis
Affected units: 46

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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