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U.S. Department of Health and Human Services

Class 3 Device Recall MediSpectra

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  Class 3 Device Recall MediSpectra see related information
Date Initiated by Firm May 15, 2007
Date Posted July 03, 2007
Recall Status1 Terminated 3 on July 09, 2007
Recall Number Z-0988-2007
Recall Event ID 37954
PMA Number P040028 
Product Classification Cervical Imaging System - 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 MA 02421-3102
Manufacturer Reason
for Recall		 Power supply may fail and render the unit inoperable.
FDA Determined
Cause 2		 Other
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MWM and Original Applicant = SPECTRA SCIENCE
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