• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH YSIO MAX SYSTEM, X-RAY, STATIONARY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SIEMENS HEALTHCARE GMBH YSIO MAX SYSTEM, X-RAY, STATIONARY Back to Search Results
Model Number YSIO MAX
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/13/2019
Event Type  malfunction  
Event Description
Metal flecks from the "collapsible tower" that x-ray tube is anchored are being found on table pad and tube housing. Potential safety issue if one should fall onto patients.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameYSIO MAX
Type of DeviceSYSTEM, X-RAY, STATIONARY
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
40 liberty boulevard
mailcode: 65-1a
malvern PA 19355
MDR Report Key8955875
MDR Text Key156296729
Report Number8955875
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberYSIO MAX
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/19/2019
Event Location No Information
Date Report to Manufacturer09/03/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-