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Terminated

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

FDA Recall Z-0836-03 · Posted 2003-05-15

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2003-04-02
Date Terminated2003-12-01
Product Quantity50 installed units (24 domestic)

Reason for Recall

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

Firm Action

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

Root Cause

Other

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010817MX8000 V5.0 CT SYSTEMPhilips Medical Systems (Cleveland), Inc. · 2001-06-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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