Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Compute
FDA device recall Z-0236-2015 · posted 2014-12-16 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc.
- Reason for recall
- It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location.
- Action taken
- Philips Healthcare is directly notifying affected users via letter. In addition, Philips Healthcare has performed the software correction for forward production and plans a Field Correction to fix the defect in the field. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 16 systems
- Distribution
- US Distribution
- Date initiated
- 2014-07-31
- Date posted
- 2014-12-16
- Date terminated
- 2017-02-16
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRILLIANCE VOLUME (K060937) | Philips Medical Systems (Cleveland), Inc. | 2006-06-05 |