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Adverse Event Report

ADAC LABORATORIES FORTE NUCLEAR MEDICINE EQUIPMENT   back to search results
Model Number 2155-3002B
Event Date 07/10/2000
Event Type  Malfunction  
Manufacturer Narrative

Investigation into collimator exchange reports have been completed. It has been concluded that an improvement to the current design of the collimator exchanger would best address this condition. Corrective and preventive action #146 has been initiated to improve the collimator exchange design of forte systems. This project is scheduled to be completed by 1/2001. No further action at this time.

 
Event Description

Head 2 collimator was stuck to detector after lock bars had been unlocked. There was no injury.

 
Manufacturer Narrative

Followup report will be submitted once investigation is completed.

 
Search Alerts/Recalls

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Brand NameFORTE
Type of DeviceNUCLEAR MEDICINE EQUIPMENT
Baseline Brand NameFORTE
Baseline Generic NameNUCLEAR MEDICINE GAMMA CAMERA
Baseline Catalogue NumberNA
Baseline Model Number2155-3002B
Baseline Device FamilyNUCLEAR MEDICINE EQUIPMENT
Baseline Device 510(K) NumberK982911
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed01/16/1998
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, dir.
540 alder dr
milpitas , CA 95035-7443
(408) 468 -3151
Device Event Key278802
MDR Report Key288101
Event Key270336
Report Number2916556-2000-00309
Device Sequence Number1
Product CodeKPS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation UNKNOWN
Remedial Action Modification/Adjustment
Type of Report Initial,Followup
Report Date 07/11/2000,07/25/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/28/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number2155-3002B
OTHER Device ID Number8867FM
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/10/2000
Device Agena
Event Location Hospital
Date Manufacturer Received07/11/2000
Was Device Evaluated By Manufacturer? Yes
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 February 28, 2009

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