A recall notice is a manufacturer action recorded by a regulator. It is not a count of how often devices fail, and it is not a ranking of brands. ProbeBridge has not published its own census of ultrasound recalls. Use the public record for the model in front of you.
Which Records to Open
Diagnostic ultrasound entries in the US FDA recall database are commonly filed under three product codes in Title 21 of the Code of Federal Regulations:
- IYO, 21 CFR 892.1560: diagnostic ultrasound systems, including consoles, acquisition electronics and displays.
- IYN, 21 CFR 892.1550: pulsed Doppler and related signal-processing functions.
- ITX, 21 CFR 892.1570: diagnostic ultrasound transducers, including the array, cable, lens, strain relief and connector.
Search the exact model, probe name and part number. A notice for another revision, another probe or another year does not automatically apply.
What the Notice is Allowed to Tell You
Read four fields before changing a buying or service decision:
- The named product. Model, catalog number and, when stated, serial or software range.
- The reason. Hardware, software, labeling, reprocessing instructions or useful-life wording. Do not collapse those into one "probe failure" bucket.
- The required action. Inspection, software update, labeling change, quarantine or return. A labeling action is not the same event as a broken array.
- The date and status. An old notice can still matter if that unit was never updated.
Do not turn those notices into a percentage of defects. The database does not contain the number of devices that worked.
Servicing is Not the Same Decision as Remanufacturing
FDA guidance separates returning a finished device to its original specification from changing its performance or intended use. Replacing a like component and checking the original function is the servicing question. Changing acoustic output, bypassing a safety interlock or rebuilding a probe so that it no longer matches the cleared device is a different regulatory question.
For a repaired or pre-owned probe, ask whether the work stayed inside the original specification and which tests show that. Do not treat age, a lens replacement or a useful-life notice as automatically acceptable or automatically fatal. Read the notice that names that model.
Incoming Check
Use this sequence when a system, board or probe arrives. It is a buying check, not a claim that ProbeBridge has tested that unit.
- Identity. Photograph the console model, software revision, board part number and revision, and the probe model and serial number. Match them to any open notice.
- Probe condition. Look at the lens, housing, strain relief and connector. Make an in-air uniformity image. Uneven reverberation is a reason to ask for an element map, not a reason to guess a dropout percentage.
- Electrical safety. After installation or service, run the leakage and protective-earth checks required by the manufacturer instructions, IEC 62353 where it applies, and the facility procedure. A bare board does not receive a finished-device certificate.
- Function. Confirm the software build, then exercise the modes that matter for that board or probe: 2D, color flow and spectral Doppler. Powering on is not the test.
- Records. Keep the notice, the test sheet and the quote exclusions with the asset. Warranty length, if any, comes from the written quote, not from this page.