FDA Medical Device Recalls (openFDA)
Philips Medical Systems, Inc.: BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components.
- Recall number
- Z-0203-2015
- Recalling firm
- Philips Medical Systems, Inc.
- Product
- BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components.
- Status
- Terminated
- Initiated
- 2013-10-23
- Posted
- 2014-12-12
- Terminated
- 2021-03-01
- Reason
- It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the time of interruption) and did not complete successfully.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Philips sent an Important Electronic Product Radiation Warning letter dated November 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken by the customer: Please be aware that if this condition occurs, users will not be able to detect the situation prior to the interruption of the CT acquisition. However, if the INFORMATION message appears during a clinical study indicating to the operator that the scan did not complete successfully, Philips advises users to understand the following available options, and use their clinical judgment to determine which option best suits their clinical needs: The operator chooses not to rescan the patient: Continue with the SPECT portion of the of the scan and use only the portion of the segments that were acquired prior to the interruption for interpretation; or The operator chooses to rescan the patient: Retry the interrupted segment acquisition. Philips Healthcare is initiating a corrective action consisting of : Distribution of this Field Safety Notice 88200485_486, Conducting the appropriate field safety correction will address the above issue that has been identified. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center (1-800-722-9377: follow the prompts).
- Quantity
- 344 units worldwide, with approximately 114 units in the United States.
- Distribution
- Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AZ, CA, CO, DC, DE, FL, GA, IL, MA, MD, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, TX, VT, WA and WI., and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Gabon, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom and Viet Nam.
- Lot, serial or model codes
- Brightview XCT
- 510(k) numbers
- ["K080927"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- 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