Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System
FDA device recall Z-0335-2014 · posted 2013-11-15 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- If the couch, with the footrest extension attached, is positioned where the table travel is within the bore of the gantry, and the user begins to lower the couch, the footrest extension can contact the gantry cover or come in contact with the user due to the length of the accessory.
- Action taken
- Philips sent an Urgent - Medical Device Correction letter dated October. 11, 2013, to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue the use of the footrest extension. Philips also, stated they will replace the old footrest extension with the current one in use. For questions contact your local Philips representative or local Philips Healthcare office.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 9 units
- Distribution
- Worldwide distribution: USA (nationwide) Distribution in the states of DC, GA, IL, IN, NY and OH and the countries: Germany, Israel and Netherlands.
- Date initiated
- 2013-10-11
- Date posted
- 2013-11-15
- Date terminated
- 2015-08-04
- Location
- Cleveland, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRILLIANCE VOLUME (K060937) | Philips Medical Systems (Cleveland), Inc. | 2006-06-05 |