BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuati

FDA device recall Z-0203-2015 · posted 2014-12-12 · Terminated

Recall details

Recalling firm

Philips Medical Systems, Inc.

Reason for recall

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.

Action taken

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).

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

KPS

Quantity affected

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 countr

Date initiated

2013-10-23

Date posted

2014-12-12

Date terminated

2021-03-01

Location

Andover, MA

Related 510(k) clearances