Recalls / —
—#152484
Product
BrightView X upgraded to XCT 882454
- FDA product code
- KPS — System, Tomography, Computed, Emission
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K080927
- Affected lot / code info
- Two systems were converted into the BrightView XCT and are included in the codes for prouct 1.
Why it was recalled
The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
All customers were notified via certified mail with return receipt. International customers were notivied via Philips employees. A field change order was initiated. Non-responders will be followed up on. Lastly, effectivenss checks will be conducted.
Recalling firm
- Firm
- Philips Medical Systems (Cleveland) Inc
- Address
- 595 Miner Rd, Cleveland, Ohio 44143-2131
Distribution
- Distribution pattern
- Products were distributed in the following states: AZ, CA, CO, DC, DE, FL, GA, IL, LA, MA, MD, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, PR, TX, VT, WA, & WI. Product was distributed internationally to the following countries: Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, France, Gabon, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russian Federation, Saudia Arabia, Slovakia, South AFrica, Apain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam.
Timeline
- Recall initiated
- 2016-12-23
- Terminated
- 2018-07-02
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #152484. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.