[Recalled] Intera 1.5T R11, Model Number 781170. Nuclear Magnetic Resonance Imaging System — There is a potential for the ceiling speaker(s) to fall from their position and… | FDA 2018-12-21

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in Netherlands and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Philips Medical Systems Nederlands

• Achieva XR 1.5T/3.0T, Model Number 781153. Nuclear Magnetic Resonance Imaging System — Class II
• Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients. — Class II
• SmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic Resonance Imaging System — Class II
• Intera 1.5T Achieva CV Nova, Model Number 781174. Nuclear Magnetic Resonance Imaging System — Class II
• Enterprise 1.5T, Model Number 781145. Nuclear Magnetic Resonance Imaging System — Class II
• SmartPath to dStream for 1.5T, Model Number 781260. Nuclear Magnetic Resonance Imaging System — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.