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Class 3 Device Recall MX8000 Computed Tomography Xray System |
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Date Initiated by Firm |
April 02, 2003 |
Date Posted |
May 15, 2003 |
Recall Status1 |
Terminated 3 on December 01, 2003 |
Recall Number |
Z-0835-03 |
Recall Event ID |
26080 |
510(K)Number |
k012009
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Product Classification |
System, X-Ray, Tomography, Computed - Product Code JAK
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Product |
Philips MX8000 IDT CT Scanner, utilizing V2.1 software. |
Code Information |
Serial Numbers: 3094 through 3196. |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Highland Heights OH 44143
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Manufacturer Reason for Recall |
Patient images may be incorrectly stored in the archive directory of a different patient.
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FDA Determined Cause 2 |
Other |
Action |
The firm mailed a ''Product Safety Notification'', dated 4/2/2003, to all affected user sites. |
Quantity in Commerce |
137 installed units (59 domestic) |
Distribution |
The units were installed in medical facilities located nationwide, and in the following foreign countries: China, Belgium, France, Austria, Germany, Italy, Netherlands, Australia, Israel, Spain, Denmark, Singapore, Switzerland, Russia, South Korea, Canada, United Kingdom, South Africa, Sweden, Japan, Brazil. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = JAK and Original Applicant = MARCONI MEDICAL SYSTEMS, INC.
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