Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1)
FDA device recall Z-0636-2007 · posted 2007-03-17 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Two conditions have been identified with the Philips Medical System Brilliance Bore ,version 2.2.1 Tumor Localization, that may lead the user to misinterpret the displayed data.
- Action taken
- Customer advisory notification letters dated 10/4/06 and 10/25/06 were sent to consignees providing short term work around instructions. Software modifications installed by the recalling firm will follow as the long term correction.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 17 units
- Distribution
- Class II Recall-Nationwide Distribution-USA including states of KY, MD, TX, RI, NJ, MA, LA, VA, PA, SC, CA, OH, and FL.
- Date initiated
- 2006-10-02
- Date posted
- 2007-03-17
- Date terminated
- 2012-03-26
- 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 |
|---|---|---|
| ACQSIM-MULTISLICE-CT, MODEL 453567042271 (K033357) | Philips Medical Systems (Cleveland), Inc. | 2004-01-09 |