Home › Philips Medical Systems Nederland B.V. › Ingenia

Ingenia

Philips Medical Systems Nederland B.V. · Model Ingenia Elition S · UDI-DI 00884838115682

LNH LNI Prescription

510(k) clearances

4,751

Adverse events (37 deaths)

711

Recalls

145

Facilities

Description

Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin.

Recalls

Date	Firm	Reason
2026-08-21	Philips North America Llc	A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21	Philips North America Llc	A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21	Philips North America Llc	A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21	Philips North America Llc	A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21	Philips North America Llc	A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21	Philips North America Llc	A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21	Philips North America Llc	A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21	Philips North America Llc	A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21	Philips North America Llc	A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the
2026-08-21	Philips North America Llc	A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.