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U.S. Department of Health and Human Services

Class 3 Device Recall Cleaning probe

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 Class 3 Recall
Cleaning probe
see related information
Date Posted August 07, 2007
Recall Status1 Open
Recall Number Z-1130-2007
Recall Event ID 38373
Premarket Notification
510(K) Number
K960330 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Cleaning probe included as an accessory to aspirators that are sterile packed single use disposable accessories to the GE InstaTrak 3500 Plus x-ray system. Probes are packaged and shipped together with the following aspirators: Straight Aspirator - 1000370-NAV, 7 French Aspirator - 100936, Keane - Moses Extended Straight Aspirator - 1000748, 15 degree aspirator - 1003895, Fried 45 Degree Aspirator - 1000541, Kuhn 90 degree Aspirator - 1000543-NAV.
Code Information No manufacturing or serial numbers.
Recalling Firm/
Manufacturer
GE OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City, Utah 84116-2862
Manufacturer Reason
for Recall
Cleaning probes used to unclog disposable aspirators may shed small particles of nylon material which may be transferred into the nasal cavity.
FDA Determined
Cause 2
DESIGN: Device Design
Action Consignees were notified by certified mail on 05/18/2007 and were told to stop using and to dispose of the affected probes.
Quantity in Commerce 67,625 units
Distribution Worldwide, including USA, Canada and France.
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.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = VISUALIZATION TECHNOLOGY, INC.
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