FDA Medical Device Recalls (openFDA)
Medispectra Inc.: MediSpectra Luma Cervical Imaging System Model Number: 3-02600
- Recall number
- Z-0988-2007
- Recalling firm
- Medispectra Inc.
- Product
- MediSpectra Luma Cervical Imaging System Model Number: 3-02600
- Status
- Terminated
- Initiated
- 2007-05-15
- Posted
- 2007-07-03
- Terminated
- 2007-07-09
- Reason
- Power supply may fail and render the unit inoperable.
- 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
- 8 units
- Distribution
- AZ, CA, FL, & NY.
- Lot, serial or model codes
- Serial Numbers: L0054, L0057, L0059, L0062
- 510(k) numbers
- not on file
- PMA numbers
- ["P040028"]
- Product code
- MWM
- Firm FEI
- 3002634893
- Firm city
- Lexington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28