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U.S. Department of Health and Human Services

Class 3 Device Recall MediSpectra

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 Class 3 Recall
MediSpectra
see related information
Date Posted July 03, 2007
Recall Status1 Terminated on July 09, 2007
Recall Number Z-0988-2007
Recall Event ID 37954
Premarket Approval
PMA Number
P040028
Product Classification Sensor,Electro-Optical(For Cervical Cancer) - Product Code MWM
Product MediSpectra Luma Cervical Imaging System Model Number: 3-02600
Code Information Serial Numbers: L0054, L0057, L0059, L0062
Recalling Firm/
Manufacturer
Medispectra Inc.
45 Hartwell Ave
Lexington, Massachusetts 02421-3102
Manufacturer Reason
for Recall
Power supply may fail and render the unit inoperable.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action MediSpectra notified users by telephone on 5/15/07 and follow-up letter. Users are requested to select a date for field servce to replace the power supply.
Quantity in Commerce 8 units
Distribution AZ, CA, FL, & NY.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MWM and Applicant = MEDISPECTRA INC
PMAs with Product Code = MWM and Applicant = SPECTRA SCIENCE
PMAs with Product Code = MWM and Applicant = SPECTRASCIENCE, INC.
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