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U.S. Department of Health and Human Services

Class 2 Device Recall Philips brand Brilliance CT Scanner System

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  Class 2 Device Recall Philips brand Brilliance CT Scanner System see related information
Date Initiated by Firm March 08, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on October 29, 2008
Recall Number Z-0787-04
Recall Event ID 27979
510(K)Number k012009  
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Philips Brilliance CT Scanner System, 6, 10 & 16 slice images.
Code Information Serial Numbers: 2555 to 2568; 3335 to 3392; 9701 to 9725.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact
440-483-3521
Manufacturer Reason
for Recall		 The CT couch may move downward to its lower limit without command.
FDA Determined
Cause 2		 Other
Action The firm contacted their Field Service Personnel by letter on 3/8/2004. The letter instructs the field personnel to immediately install the corrective firmware kits (from Siemens) on all affected units in the field.
Quantity in Commerce 97 units
Distribution The systems were installed at medical facilities located nationwide and 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = MARCONI MEDICAL SYSTEMS, INC.
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