M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540— 510(k) K014191
Substantially EquivalentPhilips Medical Systems
FDA 510(k) clearance K014191 for M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540, Substantially Equivalent on 2002-01-07. Applicant: Philips Medical Systems. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Andover, MA, US
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Adverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K014191
K-number listed on FDA's recall record- Z-1623-2026 — Philips OMNI II TEE Ultrasound Transducer
- Z-2348-2025 — 7.5MHZ Endo Transducer Probe
- Z-2387-2025 — OMNI II TEE Transducer Probe
- Z-2388-2025 — OMNI III TEE Transducer Probe
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K014191.
Data sourced from openFDA. This site is unofficial and independent of the FDA.