Philips MX8000 IDT CT Scanner, utilizing V2.1 software.
FDA device recall Z-0835-03 · posted 2003-05-15 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Patient images may be incorrectly stored in the archive directory of a different patient.
- Action taken
- The firm mailed a ''Product Safety Notification'', dated 4/2/2003, to all affected user sites.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 137 installed units (59 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, Denma
- Date initiated
- 2003-04-02
- Date posted
- 2003-05-15
- Date terminated
- 2003-12-01
- Location
- Highland Heights, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MX8000 IDT CT SYSTEM (K012009) | Marconi Medical Systems, Inc. | 2001-09-13 |