The Recall Desk
HighFDA (Devices)·Z-0002-2015·Announced 2014-10-08

Siemens Ysio Max Radiographic Systems Recalled for Image Loss Risk

Siemens is recalling Ysio Max radiographic systems because a malfunction can cause images to be lost, requiring patients to repeat examinations.

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-harm product (medical device) where the malfunction causes loss of diagnostic images and potential need for repeated examinations, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 10 Siemens Ysio Max radiographic systems. The Ysio Max is a medical device used in hospitals, clinics, and medical practices for radiographic and tomographic exposures of the whole body, including the skull, chest, abdomen, and extremities. The systems are used for pediatric, adult, and bariatric patients, as well as for intravenous interventions and emergency applications.

The recall is due to two identified malfunctions that pose a potential risk to patients. These malfunctions can cause images to be lost due to an automatic Radiology Information System (RIS) worklist update. This loss of images may cause examinations to be repeated. Additionally, image labels may be displayed incorrectly after images are generated.

The affected units are distributed nationwide in the United States, including in Utah, Missouri, Colorado, Massachusetts, Minnesota, Mississippi, Ohio, South Carolina, Michigan, and New York. The specific serial numbers affected are 24033, 24028, 24024, 24034, 24015, 24026, 24014, 24016, 24025, and 24037. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the malfunction.

The recalled product

Product
Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and ba
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Radiographic System
Hazard
Affected units
10

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 (1)

  • Siemens Ysio Max material #s: 10762470

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

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