Recall Z-0903-2019— 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: SmartPath to dStream for XR and 3.0T, Model Number 781270. 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
SmartPath to dStream for XR and 3.0T, Model Number 781270. 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.