Z-2156-2011

Brightview XCT, 3/4" Philips Medical Systems Brightview XCT is a gamma camera for Single Photon Emission...

Name: Z-2156-2011 Brightview XCT, 3/4" Philips Medical Systems Brightview XCT is a gamma camera for Single Photon Emission...
Creator: Philips Medical Systems
Published: 2011-03-28
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-03-28 / Terminated / root cause: design

FDA source

Philips Medical Systems began a recall of Brightview XCT, 3/4" Philips Medical Systems Brightview XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrated with an... on 2011-03-28. The reason FDA records is "The current Headholder to support Bright View XCT brain imaging allowed for imaging the brain but doe allow for imaging of the associated shoulder/neck area of the body". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2156-2011
Status: Terminated
Initiated: 2011-03-28
Posted: 2011-05-09
Terminated: 2011-06-22
Recalling firm: Philips North America LLC
Product: Brightview XCT, 3/4" Philips Medical Systems Brightview XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrated with an attenuation device consisting of flat panel x-ray imaging components. Brightview ECT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: The current Headholder to support Bright View XCT brain imaging allowed for imaging the brain but doe allow for imaging of the associated shoulder/neck area of the body.
Root cause tag: design
FDA root cause: Device Design
Action: Customer information sheets will be provided to all customers when the field change order commences in April 2011. Philips will implement a full change order for the installation of the new headholder to replace the old headholder, free of charge, to all affected Philips BrightView XCT SPECT/CT units. For questions regarding this recall call 408-463-3000.
Quantity in commerce: 1
Distribution: Worldwide Distribution - USA including US distribution to OH, MA, FL, VT and KY and the countries of Norway, Saudi Arabia, Belgium, Brazil, Japan, China, Poland, Austria, United Kingdom, Spain, Indonesia, Malaysia, Taiwan, Germany, United Arab Emirates, Netherland, Switzerland, Ireland, Czech Republic and Canada.
Product codes and lots: Model number: 4535-604-62131: catalog number 882350; Serial number: 6340008.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)