Z-0894-2019 Class II Terminated
FDA device recall Z-0894-2019 was initiated by Philips Medical Systems Nederlands on December 21, 2018 and is designated Class II. 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. The recall status is terminated (terminated November 19, 2020). Affected quantity: 11226 total.
Recall Details
- Product Type
- Devices
- Report Date
- March 6, 2019
- Initiation Date
- December 21, 2018
- Termination Date
- November 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11226 total
Product Description
Achieva 1.5T, Model Number 781178. 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 Pattern
U.S. Nationwide distribution.
Code Information
All systems