The Recall Desk
HighFDA (Devices)·Z-0014-2017·Announced 2016-10-12

Siemens Recalls Multix Fusion VA10 Radiographic Systems Due to Table Defect

Siemens is recalling 37 Multix Fusion VA10 radiographic systems because a 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 physical injury to patients from a medical device defect, but the source text describes the risk as 'unlikely' and does not report any actual injuries or illnesses, 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 37 units of the Multix Fusion VA10 radiographic system. The recall covers systems distributed nationwide in the United States. The Multix Fusion VA10 is used in hospitals, clinics, and medical practices for radiographic exposures of the whole body, including the skull, chest, abdomen, and extremities, and may be used on pediatric, adult, and bariatric patients.

The recall is due to a potential issue with the patient table. There is an unlikely risk that an internal part of the table may detach, causing the table top to tilt to the left side. This malfunction could result in an injury to a patient on the table.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Multix Fusion VA10 Product Usage: The Multix Fusion VA10 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 used on pediat
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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