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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 30, 2004
Date Posted August 24, 2004
Recall Status1 Terminated 3 on July 24, 2006
Recall Number Z-1394-04
Recall Event ID 29756
510(K)Number K935273  
Product Classification Camera, Scintillation (Gamma) - Product Code IYX
Product SMV FX-80 Nuclear Camera
Code Information 00000000000172, 00000000000173, 00000000000188, 00000000000203, 00000000000209, 00000000000214, 00000000000223, 0070090080-103, 0070090080-106, 0070090080-107, 0070090080-112, 0070090080-115, 0070090080-116, 0070090080-123, 0070090080-124, 0070090080-125, 0070090080-126, 0070090080-127, 0070090080-138, 0070090080-141, 0070090080-146, 0070090080-150, 0070090080-152, 0070090080-158, 0070090080-161, 0070090080-162, 0070090080-163, 0070090080-164, 0070090080-165, 0070090080-167, 0070090080-168, 0070090080-170, 0070090080-172, 0070090080-173, 0070090080-179, 0070090080-180, 0070090080-188, 0070090080-203, 0070090080-209, 0070090080-96, 0070090080-P298
Recalling Firm/
Manufacturer
General Electric Med Systems
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact Larry A. Kroger, Ph.D.
262-544-3894
Manufacturer Reason
for Recall
The detector head of a FX-80 Nuclear camera may fall from the gantry. Three potential causes have been determined. (1) A ball nut in the detector's radial drive assembly can back out of the bearing block that contains it. (2) Misalignment of the radial drive assembly. (3) Mounting bolts on the radial drive assembly may become loose, fail, or back out.
FDA Determined
Cause 2
Other
Action The detector head of a FX-80 Nuclear camera may fall from the gantry. Three potential causes have been determined. (1) A ball nut in the detector''s radial drive assembly can back out of the bearing block that contains it. (2) Misalignment of the radial drive assembly. (3) Mounting bolts on the radial drive assembly may become lose, fail, or back out.
Quantity in Commerce 41
Distribution Inside the US. Manufactured and distributed from 1993 - 2000.
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 = IYX and Original Applicant = SUMMIT NUCLEAR
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