Z-0988-2007

MediSpectra Luma Cervical Imaging System Model Number: 3-02600

Name: Z-0988-2007 MediSpectra Luma Cervical Imaging System Model Number: 3-02600
Creator: Medispectra Inc.
Published: 2007-05-15
License: https://open.fda.gov/license/

Medispectra Inc. / initiated 2007-05-15 / Terminated

FDA source

Medispectra Inc. began a recall of MediSpectra Luma Cervical Imaging System Model Number: 3-02600 on 2007-05-15. The reason FDA records is "Power supply may fail and render the unit inoperable". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0988-2007
Status: Terminated
Initiated: 2007-05-15
Posted: 2007-07-03
Terminated: 2007-07-09
Recalling firm: Medispectra Inc.
Product: MediSpectra Luma Cervical Imaging System Model Number: 3-02600
Product code: MWM Sensor, Electro-Optical (For Cervical Cancer)
Reason for recall: Power supply may fail and render the unit inoperable.
FDA root cause: 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.
Product codes and lots: Serial Numbers: L0054, L0057, L0059, L0062

Product code MWM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)