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U.S. Department of Health and Human Services

Class 2 Device Recall Fluoroscopic XRay System

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 Class 2 Recall
Fluoroscopic XRay System
see related information
Date Posted August 17, 2012
Recall Status1 Terminated on August 17, 2012
Recall Number Z-2221-2012
Recall Event ID 62798
Premarket Notification
510(K) Number
K003837 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.
Code Information Serial numbers: 2791PU2, 2797PU9, 2817PU5, 2824PU1, 2827PU4, 2899PU3, 2900PU9, 2901PU7, 2918PU1, 2919PU9, 2922PU3, 2939PU7, 3095PU7, 3103PU9, 3107PU0, 3219PU3, 3223PU5, 3224PU3, 3230PU0, 3233PU4, 3236PU7, 3358PU9, 3368PU8, 3500PU6, 3513PU9, 3514PU6, 3516PU2, 3523PU8, 3562PU6, 3580PU8, 3957PU8, 3973PU5, 3978PU4, 3994PU1, 4012PU1, 4018PU8, 4025PU3, 4029PU5, 4041PU0, 4043PU6, 4378PU6, 4394PU3, 4397PU6, 4446PU1, 4458PU6, 4767PU0, 4777PU9, 4782PU9, 4787PU8, 4793PU6, 4795PU1, 4797PU7, 4799PU3, 4800PU9, 4803PU3, 4806PU6, 4812PU4, 4813PU2, 4815PU7, 4818PU1, 4822PU3, 4827PU2, 4829PU8, 4830PU6, 4831PU4, 4835PU5, 4839PU7, 4840PU5, 4843PU9, 4844PU7, 4846PU2, 4847PU0, 4852PU0, 4853PU8, 5167PU2, 5169PU8, 5177PU1, 5179PU7, 5182PU1, 5188PU8, 5205PU0, 5208PU4, 5209PU2, 5211PU8, 5213PU4, 5216PU7, 5217PU5, 5219PU1, 5222PU5, 5224PU1, 5225PU8, 5227PU4, 5231PU6, 5233PU2, 5235PU7, 5236PU5, 5237PU3, 5239PU9, 5242PU3, 5244PU9, 5245PU6, 5246PU4, 5247PU2, 5249PU8, 5251PU4, 5260PU5, 5600PU2, 5602PU8, 5608PU5, 5610PU1, 5613PU5, 5621PU8, 5628PU3, 5643PU2, 5648PU1, 5664PU8, 5682PU0, 5683PU8, 5684PU6, 5687PU9, 5691PU1, 6002PU0, 6034PU3, 6036PU8, 6042PU6, 6046PU7, 6051PU7, 6060PU8, 6063PU2, 6093PU9, 6094PU7, 6410PU5, 6424PU6, 6438PU6, 6456PU8, 6474PU1, 6484PU0, 6495PU6, 6498PU0, 6941PU9, 6955PU9, 6959PU1, 6964PU1, 6973PU2, 6986PU4, 6994PU8, 6999PU7, 7307PU2, 7308PU0, 7315PU5, 7317PU1, 7318PU9, 7329PU6, 7330PU4, 7332PU0, 7336PU1, 7338PU7, 7373PU4, 7378PU3, 7379PU1, 7381PU7, 7395PU7, 7396PU5, 7399PU9, 7700PU8, 7719PU8, 7730PU5, 7739PU6, 7754PU5, FIB0033, FIB0046, FIB0048, FIB0051, FIB0058, FIB0065.
Recalling Firm/
Manufacturer
GE OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City, Utah 84116-2862
For Additional Information Contact Ms. Deena Pease
801-536-4516
Manufacturer Reason
for Recall
X-ray units did not meet manufacturer's specification for linearity.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action GE updated their user manual and changed their internal specifications to match those of the CFR In addition, a software code correction was to be made to forward productions in order to correct the reported defect. *** This recall issued was previously classified under an incorrect recall number. It is being reclassified with a new number. ***.
Quantity in Commerce 175 units
Distribution Worldwide Distribution - USA - Australia, Brazil, Cameroon, China, Colombia, Cyprus, The Czech Republic, Finland, France, Germany, Greece, Italy, Japan, Korea, Malaysia, The Netherlands, New Zealand, Norway, Russian Federation, Spain, Sweden, Taiwan, Turkey, UAE, UK, and Canada.
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 = JAA and Original Applicant = GE OEC MEDICAL SYSTEMS
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