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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 MediSpectrasee related information
Date Initiated by FirmMay 15, 2007
Date PostedJuly 03, 2007
Recall Status1 Terminated 3 on July 09, 2007
Recall NumberZ-0988-2007
Recall Event ID 37954
PMA NumberP040028 
Product Classification Cervical Imaging System - Product Code MWM
ProductMediSpectra 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
ActionMediSpectra 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 Commerce8 units
DistributionAZ, CA, FL, & NY.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = MWM
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