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N/A

MEDTRONIC NAVIGATION, INC. · Model 9733485 · UDI-DI 00613994316271

LNH Prescription

510(k) clearances

4,751

Adverse events (37 deaths)

711

Recalls

145

Facilities

Description

PIN 9733485 INTEGRATED SKULL PIN, 25mm

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

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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.