Corometrics 5700HAX Nautilus US Transducteur Conformity - rappel FDA Z-1162-2020

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Vendeur: tocoxpert ✉️ (16) 11.1%, Lieu où se trouve: Norcross, Georgia, US, Lieu de livraison: WORLDWIDE et de nombreux autres pays, Numéro de l'objet: 133577645975 Corometrics 5700HAX Nautilus US Transducteur Conformity - rappel FDA Z-1162-2020.

Functional Testing Service for Corometrics 5700HAX Nautilus Ultrasound Transducer that is on  FDA Recall Z-1161-2020  to determine whether it is Compliant or Non-Compliant to OEM specifications - $14.99 per unit.

FDA Recall Z-1161-2020 -  As of 15 November 2020, the update on the FDA website states that 'the manufacturer' (NOT the Original Manufacturer GE Corometrics but the Third Party Repair Service/Refurbishing/Re-manufacturing Company) has initiated the recall and not all products have been corrected or removed. This testing service is to identify the transducer units that are affected and hospital can initiate investigating what impact it had due to deteriorated or unreliable clinical throughput on patients/expectant moms and take corrective action for the reliable fetal monitoring set up.  The best practice would be to continue using these repaired transducers (with non-Corometrics parts) for monitoring patients / expectant moms if they are certified by the respective vendor for the safe use with reliable clinical diagnosis throughput after necessary corrective action is taken to bring them back to the original Philips factory specifications in conformance to the relevant or applicable FDA approval .  In October 2019, the Canadian Government  Regulatory Operations and Enforcement Branch  of Health Canada reviewed  10 Canadian incident reports of the Avalon Fetal Monitor in which stillbirth or potential need for immediate care at birth were described. In USA and internationally, there are also reports of stillbirth, neonatal death, poor neonatal outcome, and unnecessary caesarean section associated with the use of Fetal Monitors. The clinical experts have been consistently pointing out inaccurate FHR monitoring with extremely poor performance, high rate of failures with spurious or intermittent FHR more than 200 BPM when the transducers have Cloned/duplicate Nautilus Toco PCB Circuit Board, Non OEM crystals bonded with instant glue or non-conformal adhesives/process, after-market plastic cases, cable etc. as a result of deteriorated unstable ultrasound beam quality and extremely poor signal to noise ratio of Doppler waveform. Nautilus ultrasound 5700LAX/HAX transducers with Non GE crystals, Nautilus  Toco 2264LAX/HAX transducers with Cloned/Duplicate PCB Circuit Boards, (after-market, non-Corometrics) parts are extremely sporadic in contraction waveform tracing, base line drift at times missing detection or interpreting noise as a contraction. Same is the case with Philips Avalon fetal monitoring transducers M2734A, M2734B, M2735A, M2736A, M2736A, M2736AA, M2738A that are repaired using non OEM after-market parts. 

One of the attorneys from a team that is investigating Non OEM devices, put it rightly - "well designed medical device or a fetal monitor equipment is a piece of garbage when all its front end sensors/transducers such as Ultrasound 5700LAX/HAX, Toco 2264LAX/HAX are re-worked using substandard cloned Toco PCB Circuit Boards and parts. It is like you are flying a Boeing 747- 8 or Airbus 380 - 800 that has all compromised sensors for air/fluid flow, level, pressure, temperature, position, altitude, speed, oxygen, force, vibration, engine rpm!" 

This listing is for the functional test of a GE Corometrics Nautilus Ultrasound transducer 5700HAX (or 5700LAX) to provide the hospital/clinic with a report to let them know whether the device is 100% OEM or has non OEM after-Market parts. It will help the hospital to check the FDA recalls (web links provided below) and make sure that they obtain the proper documentation from the pertinent service vendor mentioning that the device with Non GE PCB Circuit Board Assy. parts is absolutely compliant with the Corometrics factory specifications, reliable and consistent in functionality for safe use on patient/expectant mom. 

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175939 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175940 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175938 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175937 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175943 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=176765 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175944 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175945 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175941 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=175942

Please note that this listing is for the functional testing as per the GE Corometrics manuals to determine whether the device is OEM or Non-OEM and not the sale of a preowned, used or brand new unit. There will be no repair, calibration performed during the testing nor any parts replaced. If the device is found to be non-OEM, the hospital administration need to make sure that it is indeed safe to use on patients. Failing to obtain certification for the units with non-OEM parts, means hospital has to take the unit out of service, physically preserve it with all the available documentation for traceability and investigate whether the past use on patients would have had any adverse effect. 

Hospital/Clinic will need to send the transducer for testing within 8 days after purchasing this listing. The turn-around time for tested transducer with the report is 4-6 working days. Expedited service is possible to be scheduled by sending ebay message and paying rush fees by way of ebay invoice.  The shipping charge is for the return shipment after testing. If any of the unit found to be 100% OEM and not working at all, it will be reported and quoted separately for the OEM quality repairs if desired. 

The functional testing and compliance audit service at hospital site for multiple units can be quoted separately if the buyer provides zip code and total number of units through ebay messaging. The on-site audit will provide identification of units as follows.

1. OEM units that have genuine/original GE Corometrics Toco transducers functioning to  OEM specs. 2. OEM compliant units that are repaired retaining OEM Toco PCB , have all the OEM parts - Generally third party companies provide written certification for 100% OEM compliance with 2 years' after repair warranty. 3. OEM compliant units that are repaired using Non-Corometrics  (after market) parts such as Toco PCB Assy.,  cable-connector assembly, plastic cases, crystals, strain gauges etc. and certified by respective service company with 3-4 years’ warranty.

4. Non OEM compliant units that are repaired using non-Corometrics  parts and no certification is issued by the the respective third party service provider.

We have separate ebay listings of Philips Avalon M2736A for the outstanding OEM quality repair service with 2 years’ overall warranty and LIFETIME warranty on crystal bonding implementing QRQube technology process. P lease watch  YouTube   videos on channel   TocoXpert   and send us ebay message for any further question or clarification.

The shipping address to send the transducers for the OEM compliance testing is as follows.

TocoXpert  /  Averon Bionics , Inc. 7094 Peachtree Industrial Blvd., Suite # 230 Peachtree Corners, GA 30071 USA Tel: +1 770 263 8090

We also provide OEM compliance audit testing and repair service for the following transducers as well as various medical devices that are listed on ebay.

GE Corometrics Toco Transducer 2260LAX GE Corometrics Toco Transducer 2260HAX GE Corometrics Toco 2260 LAX GE Corometrics Toco 2260 HAX GE Corometrics Toco 2260AAX GE Corometrics Toco Transducer 2260 AAX GE Corometrics Trimline Toco Transducer 2260 EAX GE Corometrics Nautilus Toco Transducer, Loop Style 2264 LAX / DAX / EAX / FAX / KAX / MAX GE Corometrics Nautilus Toco Transducer, Button Style 2264 HAX / AAX / BAX / CAX / GAX / JAX GE Corometrics Nautilus Toco Transducer 2264LAX    GE Corometrics Nautilus Toco Transducer 2264HAX   GE Corometrics Nautilus Ultrasound Transducer, Loop Style 5700 LAX / KAX / MAX GE Corometrics Nautilus Ultrasound Transducer, Button Style 5700 HAX / GAX / JAX GE Corometrics Nautilus Ultrasound 5700LAX GE Corometrics Nautilus Ultrasound 5700HAX GE Corometrics Ultrasound Transducer 5700AAX GE Corometrics Ultrasound Transducer 5700BAX GE Corometrics Fetal Acoustics Stimulator 0146AAY GE Corometrics Fetal Monitor 250, 259A, 259, 172, 171, 170, 120, 118, 116, 115  HP Philips Toco Transducer M1355A HP Philips Ultrasound Transducer M1356A HP Philips DECG M1364A HP Philips Avalon CTS Base Station M2720A HP Philips Avalon Wireless Toco Transducer M2725A HP Philips Avalon Wireless Ultrasound Transducer M2726A HP Philips Avalon Wireless ECG Transducer M2727A Philips Avalon Fetal Monitor FM50, FM40, FM30, FM20 Philips Avalon CL Base Station 866074 Philips Avalon CL Toco MP 866075 Philips Avalon CL Ultrasound 866076 Philips Avalon CL ECG / IUP 866077 Philips Avalon Smart Transducers Philips Avalon Toco Transducer M2734A Philips Avalon Toco MP Transducer M2734B (MP - Maternal Pulse) Philips Avalon Toco+ Transducer M2735A Philips Avalon Ultrasound Transducer M2736A Philips Avalon Ultrasound Transducer M2736AA Philips Avalon M2738A Patient Module   Spacelabs Toco Transducer 700-0022-00 Spacelabs Toco Transducer AMS-20-0048 Spacelabs Toco Transducer AMS-20-0020 Spacelabs Toco Transducer AMS-20-0022 Spacelabs Ultrasound Transducer 700-0021-00 Spacelabs Ultrasound Transducer AMS-20-0047 Spacelabs Ultrasound Transducer AMS-20-0011 Nonin Xpod Low power External SpO2 Nonin Xpod 3012 & Xpod 3013 Complete range of pulse oximetry probes such as Nellcor DS 100A, SPO2 extension cables, SPO2 adapter cables, Phaco hand-pieces and Harmonic scalpels.

Please check out other ebay listings for extremely special pricing from  $19  to  $69  per unit for the repairs of Philips Avalon fetal Toco and ultrasound smart transducers  M2734A, M2734B, M2735A, M2736A, M2736AA, M2738A, M1355A  and  M1356A.   GE Corometrics  Nautilus 2264LAX, 2264HAX  Toco and  5700LAX, 5700HAX  ultrasound transducer keeping  after-market PCB assy.,  plastic cases, crystals, cable etc. for  $19  each listed on ebay with  2 years’ warranty  and  free shipping !

 

  • Condition: GE Corometrics Nautilus 5700HAX Ultrasound transducer - functional testing and inspection to determine compliance to OEM specs, identify non-OEM parts used so that hospital can verify whether it is under FDA recall or not and obtain OEM compliance certification from the respective vendor/ company for the cloned PCB Circuit Board and other after-market Non GE Corometrics parts used in it in place of genuine GE Parts.

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