Class 2 Device Recall Fluoroscopic XRay System

• Date Initiated by Firm: October 19, 2007
• Date Posted: August 17, 2012
• Recall Status: Terminated on August 17, 2012
• Recall Number: Z-2221-2012
• Recall Event ID: 62798
• 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 UT 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: 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 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 = JAA and Original Applicant = GE OEC MEDICAL SYSTEMS