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Terminated

Intera 1.5T R11, Model Number 781170. Nuclear Magnetic Resonance Imaging System

FDA Recall Z-0886-2019 · Posted 2019-02-22

Recalling FirmPhilips Medical Systems Nederlands
Recall StatusTerminated
Product CodeLNH
Date Initiated2018-12-21
Date Terminated2020-11-19
Product Quantity11226 total

Reason for Recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Firm Action

Urgent Medical Device Correction notification letters dated December 2018 were sent to customers.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

U.S. Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030520INTERA FAMILYPhilips Medical Systems North America Co. · 2003-03-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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