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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Product Detail

Product Description GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.
Recall Number Z-2221-2012
Classification Class II
Code Info 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.
Product Distributed Qty 175 units
Reason For Recall X-ray units did not meet manufacturer's specification for linearity.

Event Detail

Event Id 62798
Product Type Devices
Status Terminated
Recalling Firm GE OEC Medical Systems, Inc
City Salt Lake City
State UT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2007-10-19
Initial Firm Notification of Consignee or Public Other
Distribution Pattern 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.