The Recall Desk
HighFDA (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.

What this means for you

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 be
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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