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U.S. Department of Health and Human Services

Class 1 Device Recall Brightview XCT

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 Class 1 Device Recall Brightview XCTsee related information
Date Initiated by FirmDecember 15, 2023
Date PostedFebruary 02, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0931-2024
Recall Event ID 93767
510(K)NumberK080927 
Product Classification System, tomography, computed, emission - Product Code KPS
ProductBrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161
Code Information All serial numbers are affected. No UDI-DI available for this product.
Recalling Firm/
Manufacturer		 Philips North America
222 Jacobs St
Cambridge MA 02141-2296
For Additional Information ContactPhilips Customer Care Solutions Center
800-722-9377
Manufacturer Reason
for Recall		Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as well as an interruption to normal system operation. If detector is positioned above center of gantry, there may be an interruption to normal system operation.
FDA Determined
Cause 2		Component design/selection
ActionOn December 15, 2023, the firm notified affected customers via URGENT Medical Device Correction letters. Customers were instructed to not position a patient's lower limbs directly under the detector below the Center of Gantry bore. Customers should circulate the notice to all users of the device for awareness and retain the letter with affected systems until the correction is complete. Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit the customer site and correct the system if necessary. If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377). As of 3/14/24, Philips will begin inspecting all affected devices in the field to ensure alignment of the radial leadscrew. Systems that are identified as having a misaligned leadscrew will undergo a report. Additionally, Philips will begin intsallation of a secondary catching mechanism (safety plate) starting in May 2024 in all devices. The firm will contact customers to coordinate these activities.
Quantity in Commerce106 US; 241 OUS
DistributionDomestic distribution nationwide. International distribution worldwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KPS
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