Recall Z-0014-2017— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0014-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-01

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2016-08-01, terminated 2016-12-13. It names one FDA 510(k) clearance: K121513. 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 pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill)applications.. Reason: Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal part of the table may detach causing the table top to tilt to the left side which could result in an injury to a patient on the table..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-08-01
Terminated: 2016-12-13
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K121513 — MULTIX FUSIONSiemens Medical Solution·cleared 2012-08-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill)applications.

Reason for recall

Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal part of the table may detach causing the table top to tilt to the left side which could result in an injury to a patient on the table.

Data sourced from openFDA. This site is unofficial and independent of the FDA.