FDA recall Z-0881-2019

Philips Medical Systems Nederlands · Class II · device

Product

Intera 1.5T Explorer/Nova Dual, Model Number 781108. Nuclear Magnetic Resonance Imaging System

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.

Distribution

U.S. Nationwide distribution.

Key facts

Status
Terminated
Initiation date
2018-12-21
Report date
2019-03-06
Termination date
2020-11-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Best, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0881-2019