The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images o
FDA device recall Z-2666-2014 · posted 2014-09-18 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Philips Healthcare received a complaint stating the system opens e-stop while sitting idle causing all movements and scan to stop. The problem has only occurred one time when the scan was out of Ready for Scan or scanning mode.
- Action taken
- A Customer Letter (FSN 72800580), Attachment #1, will be sent to all US and Canadian consignees via certified mail. Philips Key Market representatives will distribute the letter internationally. Additionally, a Field Service Engineer will contact each site to schedule time to implement the Field Change Order.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 257
- Distribution
- Nationwide Distribution incuding states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, VA, WA, and WI.
- Date initiated
- 2012-08-31
- Date posted
- 2014-09-18
- Date terminated
- 2015-07-01
- 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 |