Since introducing contemporary ultrasound probe repair to the hospital market over 25 years ago, we’ve repaired more than 120,000 probes of all makes, models, and complexity. Now the world’s largest probe repair facility, we also perform depot-level repairs for some of the biggest ultrasound OEMs.
With our patented Atlas™ testing device, we quickly diagnose probe failure down to component level. Next we use validated materials and components in our ISO13485:2016 repair process. For final testing, we use Atlas™, our AmpSafe™ electrical leakage tester, and our Advantage™ tissue mimicking phantom.
We thoroughly inspect probes not only for acute failures but also potential ones. We then recommend to the customer that these issues be addressed during the repair process to mitigate future probe failures.
In the absence of published OEM specifications, Acertara’s engineering and ultrasound physics lab measures and tests essential performance parameters and validates both the ultrasound probe repair process and materials used to ensure substantial equivalence as defined by the FDA’s 2019 510(k) Ultrasound Guidance Document, Sections 18.104.22.168, 22.214.171.124.1, 126.96.36.199, and Appendix C.
Wayne Moore, B.Sc., MBA, FASE, FAIUM
CEO – Acertara Acoustic Laboratories
Multiple OEM Certified
Less Than 1% Warranty Rate
Over 30 Patents
Years in Business, Sonora + Acertara
Common repairs available on TEEs
- Tip replacements
- Articulation cable replacement
- Failed calibration repairs
- Complex electronics
- Insertion tube restoration
General and Endocavity Probe Repairs
Common repairs available on G&E ultrasound probes
- Ultrasound lens replacement
- Housing replacement/reseal
- Strain relief
- Connector housings
- Array replacements
- Cable retermination
Atlas™ Flex Test System
Fast | Accurate | Optimized
- Five-axis automated positioning system
- Single click alignment & test
- Less than 1 minute for accurate & repeatable test results
- Works with a wide range of flat & curved array probes
APT Products & Testing Services
ISO/IEC 17025:2017 Accredited Testing & Calibration Services
- Full suite of APT products
- Participated in the clearance of hundreds of medical devices
All repair entities of ultrasound probes should be held to the same regulatory and compliance standards as applied to the original equipment.
This means that 3rd party transducer repair facilities should be held to the same regulatory and compliance standards as OEMs. Repair processes, materials used, and components such as acoustic arrays should be tested and validated to demonstrate substantial equivalence to the OEM probe. This testing should be documented and provided to the clinic upon return of the “repaired” probe.
If a “repaired” probe does not meet the imaging standards of the original OEM probe, then the probe should be regarded as not repaired. Paying for a repair that was not properly done only lowers the quality of the medical care while raising the cost.
We want to hear from you about your current probe repair challenges. Drop us an email or call and ask to speak to one of our awesome Customer Service Representatives.
1950 Lefthand Creek Lane, Longmont, CO 80501