Agency classClass IIOur severity:High FDA (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.

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 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…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Radiographic Systems
Hazard: physical-injury
device-malfunction
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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