Brilliance iCT Computed Tomography X-ray system
FDA device recall Z-0545-2016 · posted 2015-12-24 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.
- Action taken
- On 10/30/2015 the firm sent Customer Information letters to their Consignees.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 51 Units
- Distribution
- Worldwide distribution. US nationwide, Australia, Austria, Bangladesh, Belgium, Brazil, Cambodia, Canada, China, Egypt, France, Germany, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, L
- Date initiated
- 2015-10-29
- Date posted
- 2015-12-24
- Date terminated
- 2018-06-26
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRILLIANCE VOLUME (K060937) | Philips Medical Systems (Cleveland), Inc. | 2006-06-05 |