CLASS II Device recall · Reported 6 Mar 2019 · FDA Enforcement Report

Ingenia 3.0T CX recalled by Philips Medical Systems

Philips Medical Systems Nederlands is recalling Ingenia 3.0T CX, distributed nationwide in the US. The recall was initiated on 21 Dec 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll systems

Quantity recalled11226 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0904-2019
FDA event ID: 82038
Recalling firm: Philips Medical Systems Nederlands, Best
Classification: Class II
Status: Terminated
Recall initiated: 21 Dec 2018
FDA classified: 22 Feb 2019
Reported: 6 Mar 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

21 Dec 2018	Recall initiated by company
22 Feb 2019	Classified by FDA	+63 days
6 Mar 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Ingenia 3.0T CX, Model Number 781271. Nuclear Magnetic Resonance Imaging System

Where it was distributed

U.S. Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

All systems

Where was it sold?

U.S. Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

63 other products · FDA event 82038

This product is part of a recall event; the main page for the event is Achieva XR 1.5T/3.0T recalled by Philips Medical Systems.

Reported	Class	Recall	Company	Reason	Where
6 Mar 2019	CLASS II	Achieva XR 1.5T/3.0T recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Intera 1.5T Achieva CV Nova recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Enterprise 1.5T recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	SmartPath to dStream for 1.5T recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Intera 1.0T Power/Pulsar recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Ingenia Elition X recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Ingenia 3.0T recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	MR RT recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Achieva 1.5T recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Intera Achieva 1.5T Nova recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Achieva 1.5T Conversion recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Intera 1.5T Explorer/Nova Dual recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Multiva 1.5T 8 R5 (ZBO) recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Intera Achieva 1.5T Nova Dual recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Achieva 3.0T TX recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Multiva 1.5T 8 R5 recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Intera 1.5T recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Intera Achieva 1.5T Pulsar recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Multiva 1.5T 16 R5 (ZBO) recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Ingenia 1.5T CX (ZBO) recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Intera 1.5T R11 recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Achieva 3.0T X-series recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Ingenia 1.5T recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Achieva 7.0T recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Intera 1.5T Omni/Stellar recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Ingenia 1.5T S recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Marlin 1.5T recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Mr-or 3.0T recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	NZM101 Ingenia 1.5T Linac recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Achieva 3.0T X recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Intera 1.5T Power/Pulsar recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Intera 1.5T CV recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Ingenia 1.5T CX recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Multiva 1.5T recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Multiva 1.5T 16 R5 recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Intera 1.0T Omni/Stellar recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Achieva 1.5T High Performance recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Intera 3.0T Master/Quasar Dual recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Prodiva CS recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Ingenia 1.5T recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Achieva 3.0T TX for PET recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Panorama 1.0T recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Intera 1.5T Master/Nova recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Intera Achieva 1.5T IT Nova Dual recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Ingenia 3.0T recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Achieva 3.0T TX-series recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Achieva 1.5T Conversion recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Intera IT recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Prodiva CX recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Achieva XR 1.5T/3.0T recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Intera Achieva 1.5T IT Nova recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Achieva 1.5T recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Ingenia Ambition X recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Ingenia Elition S recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Achieva 3.0T recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Ingenia Ambition S recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Mr-or 1.5T recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Achieva 3.0T for PET recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Panorama 1.0T recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Intera 0.5T Standard recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Achieva 1.5T recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide
6 Mar 2019	CLASS II	Intera 1.5T High Performance recalled by Philips Medical Systems	Philips Medical Systems Nederlands	Other	Nationwide

More recalls from Philips Medical Systems Nederlands

All 79

Reported	Class	Recall	Company	Reason	Where
30 Jun 2021Device	CLASS II	Philips Allura Xper System: Interventional Fluoroscopic recalled	Philips Medical Systems Nederlands	Device Malfunction	10 states
7 Aug 2019Device	CLASS II	Azurion lnterventional Fluoroscopic X-ray System recalled	Philips Medical Systems Nederlands	Device Malfunction	Nationwide
8 May 2019Device	CLASS II	Ingenia Ambition S (781359), Ingenia Ambition X recalled	Philips Medical Systems Nederlands	Other	FL
24 Apr 2019Device	CLASS II	Foot Switches used with the following systems recalled	Philips Medical Systems Nederlands	Other	Nationwide
24 Apr 2019Device	CLASS II	Foot Switches used with Philips MultiDiagnost Eleva recalled	Philips Medical Systems Nederlands	Other	Nationwide

Other Imaging Equipment recalls

All 2,336

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled	Canon Medical System USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederl	Potency & Assay