Brilliance 64 S/N 9089, 9551, 9548. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-se
FDA device recall Z-1820-2011 · posted 2011-03-24 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- During the version 2.6 software upgrade, the system was not recalibrated with the infant phantom for the infant protocol.
- Action taken
- Philips sent an URGENT - Medical Device Correction letter dated January 31, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers may consider reviewing any infant images that may have been affected during the Field Test to confirm reading accuracy. For further information or support concerning this issue, customers could contact their local Philips representative or local Philips Healthcare office for North America and Canada contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID or follow the prompts)
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 3
- Distribution
- Worldwide Distribution - USA including CO, IN, and TN and the countries of Norway, Israel, and Germany
- Date initiated
- 2010-12-20
- Date posted
- 2011-03-24
- Date terminated
- 2013-02-22
- Location
- Cleveland, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM (K033326) | Philips Medical Systems, Inc. | 2003-10-29 |