Brilliance CT Systems 64 slice configuration. Computed tomography scanner.
FDA device recall Z-0111-2008 · posted 2007-10-31 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Two potential artifacts may appear in some images from head scans on the Brilliance 40/64 systems. These artifacts may lead to misdiagnosis.
- Action taken
- Firm notified its customers via a Product Safety Notification letter dated May 25, 2007, warning the user of a possible appearance of artifacts which could lead to a misdiagnosis and improper treatment.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 633
- Distribution
- Worldwide, including USA, Canada, Argentina, Austria, Australia, Bangladesh, Belgium, Brazil, Chile, China, Colombia, Denmark, Ecuador, Egypt, England, Equatorial Guinea, Finland, France, Germany, Gre
- Date initiated
- 2007-05-25
- Date posted
- 2007-10-31
- Date terminated
- 2012-09-24
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM (K033326) | Philips Medical Systems, Inc. | 2003-10-29 |