FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

ADAC LABORATORIES PINNACLE3 RADIATION THERAPY PLANNING EQUIPMENT   back to search results
Model Number 9200-0555A
Event Date 09/12/2000
Event Type  Malfunction  
Event Description

It was reported to adac that the pt image info is incorrect when reported with two different magnifications. The user reported that there was a break in the slices. No injuries were repored as a result of this issue.

 
Manufacturer Narrative

The "dicom" server does not validate that all of the field of view dimensions are identical for every image transferred. The pinnacle file format only supports a single field of view for all images in the volume. Pinnacle does not warn the user when images are imported with different magnifications in the scan. This is written in the scanning protocol as a warning, page 3-5 image scanning guidelines 1998-07.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NamePINNACLE3
Type of DeviceRADIATION THERAPY PLANNING EQUIPMENT
Baseline Brand NamePINNACLE3
Baseline Generic NameACCELERATOR, LINEAR, MEDICAL
Baseline Catalogue NumberNA
Baseline Model Number9200-0555A
Baseline Device FamilyRADIATION THERAPY PLANNING EQUIPMENT
Baseline Device 510(K) NumberK951581
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed11/27/1992
Manufacturer (Section F)
ADAC LABORATORIES
540 alder dr.
milpitas CA 95035 7443
Manufacturer (Section D)
ADAC LABORATORIES
540 alder dr.
milpitas CA 95035 7443
Manufacturer (Section G)
ADAC LABORATORIES
540 alder drive
milpitas CA 95035 7443
Manufacturer Contact
cliff case, director
540 alder drive
milpitas , CA 95035-7443
(408) 468 -3151
Device Event Key290317
MDR Report Key299931
Event Key281778
Report Number2916556-2000-00348
Device Sequence Number1
Product CodeIYE
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 10/06/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/06/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number9200-0555A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/12/2000
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/1999
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

Database last updated on January 30, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH