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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS XCELERA LLZ (SYSTEM, IMAGING PROCESSING, RADIOLOGICAL)

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PHILIPS MEDICAL SYSTEMS XCELERA LLZ (SYSTEM, IMAGING PROCESSING, RADIOLOGICAL) Back to Search Results
Model Number 830032
Event Date 01/04/2009
Event Type  Other  
Manufacturer Narrative

Conclusions: the responsibility for the maintenance of the it equipment (which requires amongst others the installation of the microsoft office security patches of virus scanners) lies with the customer. Philips medical systems is not responsible for the installation or maintenance of antivirus software or for the integrity of the xcelera system infected with a computer virus. Appropriate network firewalls and virus protection is not the responsibility of philips. Although philips understands the customer's point of view, philips believes that the medical device was not a contributor to the worm attack. There were no reported injuries. Philips is only reporting this matter due to the hospital's safety reported claims.

 
Event Description

The report is being filed upon notification from our info technology manufacturer in (b)(4) to submit this event. In a retrospective review of philips complaints/corrective actions, this issue is now being reported as a mdr. Several computers in the hospital (b)(6)got infected with a computer virus. As a result of this infection, the software (xcelera) could not be used from time to time. This hospital felt that this could have caused a death or serious health deterioration.

 
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Brand NameXCELERA
Type of DeviceLLZ (SYSTEM, IMAGING PROCESSING, RADIOLOGICAL)
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
veenpluis 4-6
po box 10.000
best 5680 DA
NETHERLANDS 5680 DA
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
veenpluis 4-6
po box 10.000
best 5680 DA
NETHERLANDS 5680 DA
Manufacturer Contact
drew queen
22100 bothell everett hwy
bothell , WA 98041
4254877199
MDR Report Key1568388
Report Number3003768277-2009-00159
Device Sequence Number1
Product CodeLLZ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 05/06/2009
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/10/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number830032
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/06/2009
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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