medical MODERATE Updated 2017-02-22

Philips Medical Systems (Cleveland) Inc recalls BrightView X upgraded to XCT 882454

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Recalled Product

BrightView X upgraded to XCT 882454

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Hazard / Issue

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.

Issued by

FDA

Affected States: AZ, CA, CO, DC, DE, FL, GA, IL, LA, MA, MD, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, TX, VT, WA, WI
Lot/Code Info: Two systems were converted into the BrightView XCT and are included in the codes for prouct 1.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

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