Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2017 - (Recall #: Z-1187-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

BrightView X upgraded to XCT 882454

Product Classification:

Class II

Date Initiated: December 23, 2016

Date Posted: February 22, 2017

Recall Number: Z-1187-2017

Event ID: 76183

Reason for Recall:

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.

Status: Terminated

Product Quantity: N/A

Code Information:

Two systems were converted into the BrightView XCT and are included in the codes for prouct 1.

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.

Voluntary or Mandated:

Voluntary: Firm initiated