FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Philips MX8000 Dual v. EXP CT Scanner, utilizing V2.0 software.
- Recall number
- Z-0836-03
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Philips MX8000 Dual v. EXP CT Scanner, utilizing V2.0 software.
- Status
- Terminated
- Initiated
- 2003-04-02
- Posted
- 2003-05-15
- Terminated
- 2003-12-01
- Reason
- Patient images may be incorrectly stored in the archive directory of a different patient.
- Root cause
- Other
- Action
- The firm mailed a ''Product Safety Notification'', dated 4/2/2003, to all affected user sites.
- Quantity
- 50 installed units (24 domestic)
- Distribution
- The units were installed in medical facilities located nationwide, and in the following foreign countries: China, Belgium, France, Austria, Germany, Italy, Netherlands, Australia, Israel, Spain, Denmark, Singapore, Switzerland, Russia, South Korea, Canada, United Kingdom, South Africa, Sweden, Japan, Brazil.
- Lot, serial or model codes
- Serial Numbers: 8008 through 8069.
- 510(k) numbers
- ["K010817"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 1525965
- Firm city
- Highland Heights
- Firm state
- OH
- 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