| Class 2 Device Recall | |
Date Initiated by Firm | July 30, 2004 |
Date Posted | August 24, 2004 |
Recall Status1 |
Terminated 3 on July 24, 2006 |
Recall Number | Z-1393-04 |
Recall Event ID |
29756 |
510(K)Number | K935273 |
Product Classification |
Camera, Scintillation (Gamma) - Product Code IYX
|
Product | SMV FX-40 Nuclear Camera |
Code Information |
00000000000194, 00000000000222, 0070090040-100, 0070090040-101, 0070090040-105, 0070090040-111, 0070090040-113, 0070090040-114, 0070090040-117, 0070090040-120, 0070090040-122, 0070090040-128, 0070090040-129, 0070090040-131, 0070090040-132, 0070090040-133, 0070090040-134, 0070090040-136, 0070090040-137, 0070090040-139, 0070090040-144, 0070090040-147, 0070090040-148, 0070090040-149, 0070090040-151, 0070090040-154, 0070090040-156, 0070090040-157, 0070090040-159, 0070090040-160, 0070090040-166, 0070090040-171, 0070090040-175, 0070090040-177, 0070090040-182, 0070090040-183, 0070090040-185, 0070090040-189, 0070090040-190, 0070090040-192, 0070090040-193, 0070090040-195, 0070090040-196, 0070090040-197, 0070090040-198, 0070090040-199, 0070090040-200, 0070090040-201, 0070090040-202, 0070090040-204, 0070090040-205, 0070090040-206, 0070090040-207, 0070090040-208, 0070090040-210, 0070090040-211, 0070090040-212, 0070090040-213, 0070090040-215, 0070090040-216, 0070090040-217, 0070090040-219, 0070090040-221, 0070090040-222, 0070090040-939 |
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 | 65 |
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
|
|
|
|