Agency classClass IIOur severity:High FDA (Devices)·Z-0013-2017·Announced 2016-10-12

Siemens Recalls Multix Fusion X-Ray Systems Due to Table Tilt Risk

Siemens is recalling 37 Multix Fusion X-ray systems because an internal table part may detach, causing the table to tilt and potentially injure patients.

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 involves a risk-of-harm product where injury has not yet been reported, and the agency classifies it as Class II without specific hospitalization reports in the source text.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 37 Multix Fusion Stationary X-Ray Systems. The recall is due to a potential issue with the patient table where an internal part may detach. This detachment could cause the table top to tilt to the left side, which could result in an injury to a patient on the table.

The affected systems are used in hospitals, clinics, and medical practices for radiographic exposures of the whole body, including the skull, chest, abdomen, and extremities. The systems may be used on pediatric, adult, and bariatric patients, as well as for intravenous interventions and emergency applications. The recall covers systems with Model Numbers 10762470, 10893300, and 10746665, and specific serial numbers listed in the agency record.

The agency classifies this as a Class II recall. Siemens became aware of the potential issue and is taking action to address the risk of patient injury associated with the table mechanism.

The recalled product

Product: Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen and extremities and may…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Radiographic Equipment
Hazard: fall-injury
mechanical-failure
Affected units: 37

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)

Model Number: 10762470
10893300
10746665 Serial Numbers: 24644
24613
24615
40328
24611
24612
24614
40326
40322
40316
24599
24600
40404
24634
2464124590
40402
1314
40312

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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