• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MultiDiagnost MD3

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
MultiDiagnost MD3
see related information
Date Posted September 24, 2009
Recall Status1 Open
Recall Number Z-1663-2009
Recall Event ID 53034
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product MultiDiagnost MD3
Code Information Site Numbers: 6838, 6931, 13661, 26071, 35471, 38289, 38418, 38422, 38442, 38714, 38716, 40941, 41032, 41271, 50317, 62502, 76329, 82673, 100637, 101151, 101155, 103043, 103856, 557859, 557979, 43166722, 47317193, and 49794671 (or 6931).
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell, Washington 98021-8431
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The x-ray system fail to meet the requirements of 21 CFR 1020.32(d)(2)(ii) when a specific tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
Action A Customer Notification letter describing the potential grid switch failure and actions planned by Philips to correct the problem will be sent to all users of the affected systems during the week of July 6, 2009.
Quantity in Commerce 28 units distributed in US
Distribution Worldwide Distribution
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.
-
-