Medical Device Recall: Z-0013-2017

FDA Recalls dataset · Firm: Siemens Medical Solutions USA, Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2016-08-01 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0013-2017.

Recall Res Number
Z-0013-2017
Recalling Firm / Manufacturer
FEI Number
2240869
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2016-08-01
Date Posted
N/A
Date Terminated
2016-12-13
Product Code
KPR
Event Number
75126
Product Quantity
37 Systems
Product Description 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 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.

Action Details Siemens sent a Customer Safety Advisory Notice letter dated August 4, 2016 to their customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to discontinue use of the tables until one of their service technicians can inspect the affected part of each table.

Distribution Pattern US Nationwide Distribution

Code Information / Serial Numbers Model Number: 10762470, 10893300, 10746665 Serial Numbers: 24644,24613,24615,40328,24611,24612,24614,40326,40322,40316,24599,24600,40404,24634,2464124590,40402,1314,40312,24591,24592,40327,40323,24656,24659,40335,1315,40332,40403,24605,40325,40313,24645,24610,24580,24648,24581

Related Establishments / Registrations

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