FDA Medical Device Recalls (openFDA)
Philips Medical Systems: 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.
- Recall number
- Z-2156-2011
- Recalling firm
- Philips Medical Systems
- 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.
- Status
- Terminated
- Initiated
- 2011-03-28
- Posted
- 2011-05-09
- Terminated
- 2011-06-22
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Model number: 4535-604-62131: catalog number 882350; Serial number: 6340008.
- 510(k) numbers
- ["K080927"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 1525965
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28