Z-0886-2019 Class II Terminated
FDA device recall Z-0886-2019 was initiated by Philips Medical Systems Nederlands on Dec 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 Nov 19, 2020). Affected quantity: 11226 total.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 6, 2019
- Initiation Date
- Dec 21, 2018
- Termination Date
- Nov 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11226 total
Product Description
Intera 1.5T R11, Model Number 781170. 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0886-2019
- openFDA file date
- Oct 19, 2026
- Loaded by RegDataLab
- Oct 21, 2026