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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ARTISTE NV SYSTEM; ACCELERATOR, LINEAR, MEDICAL
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SIEMENS MEDICAL SOLUTIONS USA, INC. ARTISTE NV SYSTEM; ACCELERATOR, LINEAR, MEDICAL Back to Search Results
Model Number 08139789
Device Problems Labelling, Instructions for Use or Training Problem (1318); Inadequate Instructions for Healthcare Professional (1319)
Patient Problem No Patient Involvement (2645)
Event Date 05/02/2014
Event Type  No Answer Provided  
Event Description
The customer notified siemens on (b)(6) 2014 that the 2013 physics primer manual, print no.T2-000-621.28.04.02 is missing all info regarding d1_co calibration for conventional flat beams.
 
Manufacturer Narrative
Siemens was notified of the reported issue on (b)(4) 2014.This mdr is being sent to the fda through the webtrader portal on (b)(4) 2014.The investigation is on-going and a supplemental report will be submitted upon completion.There is no report of adverse event or product malfunction.There is no actual product involved in the reported issue.
 
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Brand Name
ARTISTE NV SYSTEM
Type of Device
ACCELERATOR, LINEAR, MEDICAL
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 valley stream parkway
ms - d02
malvern PA 19355
Manufacturer Contact
marlynne galloway
51 valley stream pkwy
ms - d02
malvern, PA 19355
6102195361
MDR Report Key3904710
MDR Text Key17990043
Report Number2910081-2014-03962
Device Sequence Number1
Product Code IYE
Combination Product (y/n)N
Reporter Country CodeLE
PMA/PMN Number
K121295
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/02/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number08139789
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/02/2014
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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