—#130194

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.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K080927
Affected lot / code info: Brightview XCT

Why it was recalled

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 (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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).

Recalling firm

Firm: Philips Medical Systems, Inc.
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-10-23
Posted by FDA: 2014-12-12
Terminated: 2021-03-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130194. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.