PlainRecalls
FDA Devices Moderate Class II Terminated

Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic 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.) ad emergency (trauma, critical ill) applications. Exposures may be taken with the

Reported: June 11, 2014 Initiated: May 9, 2014 #Z-1717-2014

Product Description

Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic 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.) ad emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio System is not meant for mammography. The Ysio uses an integrated or portable digital detector for generating diagnostic images by converting x-rays into electronic signals. Ysio is also designed to be used with conventional film/screen or Computed Radiography *CR) cassettes.

Reason for Recall

Excessive usage of cleaning liquid on Siemens Ysio Systems may cause infiltration of the generator console, which may lead to a short circuit causing an unintended release of radiation.

Details

Units Affected
433
Distribution
US Nationwide
Location
Malvern, PA

Frequently Asked Questions

What product was recalled? ▼
Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic 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.) ad emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio System is not meant for mammography. The Ysio uses an integrated or portable digital detector for generating diagnostic images by converting x-rays into electronic signals. Ysio is also designed to be used with conventional film/screen or Computed Radiography *CR) cassettes.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 433.
Why was this product recalled? ▼
Excessive usage of cleaning liquid on Siemens Ysio Systems may cause infiltration of the generator console, which may lead to a short circuit causing an unintended release of radiation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 11, 2014. Severity: Moderate. Recall number: Z-1717-2014.

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