GE Healthcare
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1. GE Healthcare URGENT FIELD SAFETY NOTICE 9900 Innovation Drive Wauwatosa WI 53226 USA lt Date of Letter Deployment gt GEHC Ref 30073 2 To Director of Biomedical Engineering Chief of Nursing Healthcare Administrator Risk Manager RE Improper assembly of GE Healthcare T2100 and T2000 Treadmill power cords GE Healthcare has recently become aware of a potential safety issue due to improper assembly associated with the power cords of your T2100 and T2000 Treadmills Please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions Safety Issue Safety Instructions Affected Product Details A GE Healthcare internal quality inspection has found that the power cord connecting directly to the T2100 and T2000 Treadmills may not have been assembled according to specifications If the power cord was improperly assembled and a separate secondary electrical fault condition exists e g a frayed extension or power cord touching the treadmill chassis this could possibly result in an electrical shock to the patient or operator There have been no reported incidences of the Treadmill power cord leading to an electrical shock of a patient or operator at this time Visual inspection alone cannot be used to detect improper assembly of the power cord The potential for the electrical shock hazard described above can be determined through the monthly leakage current tests performed2. by qualified and trained personnel after internal cleaning as specified in the T2100 and T2000 Service Manuals If the results of monthly leakage current tests have been and continue to be acceptable this indicates the chassis is not energized and that no secondary fault as described above is present at the time of the test If the leakage current tests do not pass do not use the equipment and call GE Healthcare Tech Support for assistance You should continue to request routine maintenance as specified in the T2100 and T2000 Service manuals If routine product maintenance as specified in the T2100 and T2000 Service manuals is not currently being performed on your device you should request these maintenance activities immediately and ensure that they are continued as specified in the manuals Note The Service Manual written in English language is not directed to the end user but to qualified and trained professionals This Safety Notice is addressed to the owner end user of the device in order to make sure that the above mentioned Service activities will be performed until the final solution is implemented This issue can occur on GE Healthcare T2100 and T2000 Treadmills with power cord part numbers e 408930 001 all revisions manufactured from June 1st 2006 to December 10th 2014 Power cords outside these dates or marked with a RWK label adjacent to the part number label have been inspected and are assembled correctly For examp
3. e has been notified to the appropriate Regulatory Agency Please be assured that maintaining a high level of safety and quality is our highest priority If you have any questions please contact us immediately per the contact information above Sincerely Vice President Devices Acting Chief Medical Officer GE Healthcare GE Healthcare Page 2 of 2
4. le a power cord dated 2014 OCT 13 with the RWK label is correct and no further action is required Page 1 of 2 5 989300 E REV E 20140c743 i 7 Figure 1 Incorrect power cord Figure 2 Correct power cord falls within date range in date range with RWK label e 408930 002 all revisions manufactured from June 1st 2006 to January 19th 2015 Power cords outside these dates are assembled correctly and no further action is a i Figure 1 Improperly assembled power cord falls in date range e 2028038 008 all revisions manufactured from December 1st 2006 to January 28th 2015 Power cords outside these dates are assembled correctly and no further action is required Figure 2 Improperly assembled power cord falls in date range e NOTE Alternate four digit date codes may appear on some power cords rather than an actual date as shown above The first two digits represent the year manufactured The second two digits the week manufactured For example 0648 would be read as 2006 week 48 or the week of November 26 2006 Product GE Healthcare will correct all affected systems at no cost to you A GE Healthcare Service Correction Representative will contact you to arrange for this correction Contact If you have any questions or concerns regarding this notification please contact GE Information Healthcare Service or your local Service Representative at lt Local contact data gt GE Healthcare confirms that this notic
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