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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance CT XRay System

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 Class 2 Recall
Brilliance CT XRay System
see related information
Date Posted September 27, 2011
Recall Status1 Terminated on March 15, 2013
Recall Number Z-3281-2011
Recall Event ID 59383
Premarket Notification
510(K) Number
K033326 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Brilliance 64 Computed Tomography System, Model #78231, Serial Number: 9592. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Code Information Model #78231, 510(k) #K03326, Serial Number: 9592.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland, Ohio 44143-2131
Manufacturer Reason
for Recall
Component defect. Philips Medical decided to conduct a recall field /correction (rework) of the mounting key locking threaded insert of the Detector Module system (DMS) bolt on one (1) Brilliance 64 CT X-ray unit. The firm initiated this action following Philip's receipt of the customer's complaint reporting that the retaining inserts were pulling out of the rotor during the removal of the UDMS
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Philips sent a Field Change Order (FCO) 72800519 on June 13, 2011 to the affected customer. A Field Service Engineer visited the customer site and installed a hardware upgrade to the affected Brilliance 64 device system (Serial Number: 9592). The correction action was completed on August 9, 2011. For questions regarding this recall call 1-440-483-7000.
Quantity in Commerce 1 unit
Distribution Nationwide Distribution including PA
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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