Philips Medical Systems Nederlands: Medical Device Recall in 2019 - (Recall #: Z-0913-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Achieva 3.0T X, Model Number 781344. Nuclear Magnetic Resonance Imaging System

Product Classification:

Class II

Date Initiated: December 21, 2018

Date Posted: March 6, 2019

Recall Number: Z-0913-2019

Event ID: 82038

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.

Status: Terminated

Product Quantity: 11226 total

Code Information:

All systems

Distribution Pattern:

U.S. Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated