Recall Z-0872-2019— Philips Medical Systems Nederlands

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems Nederlands, initiated 2018-12-21, terminated 2020-11-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Multiva 1.5T 16 R5 (ZBO), Model Number 781073. Nuclear Magnetic Resonance Imaging System. Reason: 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..

Recalling firm
Philips Medical Systems Nederlands
Classification
Class II
Status
Terminated
Initiated
2018-12-21
Terminated
2020-11-19
Firm location
Best, Netherlands

Product description

Multiva 1.5T 16 R5 (ZBO), Model Number 781073. 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.