Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Bod
FDA device recall Z-1745-2014 · posted 2014-06-22 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- During internal testing, the Brilliance CT Big Bore was found to be out of tolerance for radio frequency emissions. Specifically, at the 48MHZ frequency, the testing indicated the Brilliance CT Big Bore was 3.5dB uV/meter higher than the applicable IEC 60601-1-2 standard specification.
- Action taken
- Philips Medical System sent an Urgent Medical Device Corrections letters dated December 10, 2013 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that a field service Engineer will visit the facility to perform an Electro-Magnetic Interference (EMI) noise reduction up0date on each system. For information or support concerning contact your local Philips representative: For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, OptionS: Enter site ID or follow prompts).
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 454 Units
- Distribution
- Worldwide Distribution - US (nationwide) in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC
- Date initiated
- 2013-12-19
- Date posted
- 2014-06-22
- Date terminated
- 2015-08-25
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACQSIM-MULTISLICE-CT, MODEL 453567042271 (K033357) | Philips Medical Systems (Cleveland), Inc. | 2004-01-09 |