Z-0836-03

Philips MX8000 Dual v. EXP CT Scanner, utilizing V2.0 software

Name: Z-0836-03 Philips MX8000 Dual v. EXP CT Scanner, utilizing V2.0 software
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2003-04-02
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2003-04-02 / Terminated

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Philips MX8000 Dual v. EXP CT Scanner, utilizing V2.0 software on 2003-04-02. The reason FDA records is "Patient images may be incorrectly stored in the archive directory of a different patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0836-03
Status: Terminated
Initiated: 2003-04-02
Posted: 2003-05-15
Terminated: 2003-12-01
Recalling firm: Philips North America LLC
Product: Philips MX8000 Dual v. EXP CT Scanner, utilizing V2.0 software.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Patient images may be incorrectly stored in the archive directory of a different patient.
FDA root cause: Other
Action: The firm mailed a ''Product Safety Notification'', dated 4/2/2003, to all affected user sites.
Quantity in commerce: 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.
Product codes and lots: Serial Numbers: 8008 through 8069.

Product code JAK

K010817Class IIMx8000 V5.0 CT SystemPhilips Medical Systems (Cleveland), Inc. / cleared 2001-06-15

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)