Benchmark logic. Each product is scored 0–100 across five domains —
patient safety, product quality, security, privacy, regulatory. The
composite = unweighted mean of the five domain scores. Bands:
Strong 75–100 · Moderate 55–74 · Watch 35–54 · Weak 0–34. Scoring is
remediation-aware — fully remediated issues on predecessor, EOL, or non-US models do not penalize the current product. Every assessment carries a
confidence level:
High = verified against primary FDA/manufacturer sources (an
assessed result);
Medium/Low = preliminary baseline from public materials (an
estimated result). Advisory impact is shown as
Impacted (red — confirmed affected) vs
Likely (yellow — mapped by component/class, not confirmed).
Important — what these scores are and are not. Scores are relative posture indicators for risk governance and prioritization only. They are not safety certifications, endorsements, FDA clearances or determinations, and not statements that any device is unsafe, defective, or non-compliant. Many assessments are preliminary baselines derived from public information and may be incomplete or out of date. Advisory-impact flags marked Likely/Possible are estimates by shared component or class, not confirmations of exposure. Manufacturers may dispute any score or finding with supporting evidence via the contact form; substantiated rebuttals are incorporated and re-versioned. This is not legal, regulatory, or medical advice.