Intera 1.0T Omni/Stellar, Model Number 781102. Nuclear Magnetic Resonance Imaging System
FDA Recall Z-0875-2019 · 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.