Z-1187-2017Class II

BrightView X upgraded to XCT 882454

Name: Z-1187-2017 BrightView X upgraded to XCT 882454
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2016-12-23
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-12-23 / Terminated

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of BrightView X upgraded to XCT 882454 on 2016-12-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1187-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-23
Posted: 2017-02-10
Terminated: 2018-07-02
Recalling firm: Philips North America LLC
Product: BrightView X upgraded to XCT 882454
Product code: KPS System, Tomography, Computed, Emission
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.
FDA root cause: Under Investigation by firm
Action: 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.
Distribution: 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.
Product codes and lots: Two systems were converted into the BrightView XCT and are included in the codes for prouct 1.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1187-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1186-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-10
Z-1187-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-10

Product code KPS

K080927Class IIBrightview Vct Imaging SystemPhilips Medical Systems (Cleveland), Inc. / cleared 2008-04-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)