Recalls / —

—#27028

Product

Philips MX8000 IDT CT Scanner, utilizing V2.1 software.

FDA product code

JAK — System, X-Ray, Tomography, Computed

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K012009

Affected lot / code info

Serial Numbers: 3094 through 3196.

Why it was recalled

Patient images may be incorrectly stored in the archive directory of a different patient.

Root cause (FDA determination)

Other

Action the firm took

The firm mailed a ''Product Safety Notification'', dated 4/2/2003, to all affected user sites.

Recalling firm

Firm

Philips Medical Systems (Cleveland) Inc

Address

595 Miner Rd, Highland Heights, Ohio 44143

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2003-04-02

Posted by FDA

2003-05-15

Terminated

2003-12-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #27028. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.