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U.S. Department of Health and Human Services

Class 1 Device Recall Brightview

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  Class 1 Device Recall Brightview see related information
Date Initiated by Firm December 15, 2023
Date Posted February 02, 2024
Recall Status1 Open3, Classified
Recall Number Z-0929-2024
Recall Event ID 93767
510(K)Number K062298  
Product Classification System, tomography, computed, emission - Product Code KPS
Product BrightView, gamma camera system;

Model Nos.:

6-digit format 882480;
12-digit format 453560279781
453560279791
453560279811
453560279801;
4x4 digit format
2170-3000A
2170-3001A
2170-3002A
2170-3003A

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 Contact Philips 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
Action On 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).
Quantity in Commerce 302 US; 264 OUS
Distribution Domestic distribution nationwide. International distribution worldwide.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KPS and Original Applicant = ADAC LABORATORIES
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