Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BrightView X upgraded to XCT 882454 Recalled by Philips Medical Systems (Cleveland) Inc Due to The intended use listed in the English and...

Date: December 23, 2016
Company: Philips Medical Systems (Cleveland) Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips Medical Systems (Cleveland) Inc directly.

Affected Products

BrightView X upgraded to XCT 882454

Quantity: N/A

Why Was This 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.

Where Was This Sold?

This product was distributed to 26 states: AZ, CA, CO, DE, FL, GA, IL, LA, MD, MA, MN, MS, MO, MT, NJ, NY, NC, OH, OK, OR, PA, TX, VT, WA, WI, DC

Affected (26 states)Not affected

About Philips Medical Systems (Cleveland) Inc

Philips Medical Systems (Cleveland) Inc has 313 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report