FDA Device

Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System

Hazard

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.

What You Should Do

Remedy

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

Products

Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System
Brand
Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands
UPC
All systems

Units Affected

11226 total