CLASS II ONGOING Device recall · Reported 21 Jul 2021 · FDA Enforcement Report

Signa PET/MR, Tomographic Imager Combining Emission recalled

GE Healthcare is recalling Signa PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear. The recall was initiated on 4 Jun 2021 and the FDA has classified it as Class II.

Recall details

Recall number: Z-2057-2021
FDA event ID: 88147
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 4 Jun 2021
FDA classified: 12 Jul 2021
Reported: 21 Jul 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

4 Jun 2021	Recall initiated by company
12 Jul 2021	Classified by FDA	+38 days
21 Jul 2021	Published in enforcement report	+9 days

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

Reason for recall

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Where it was distributed

Worldwide distributions.

Questions about this recall

Why was it recalled?

Where was it sold?

Worldwide distributions.

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

13 other products · FDA event 88147

This product is part of a recall event; the main page for the event is Signa Premier recalled by GE Healthcare.

Reported	Class	Recall	Company	Reason	Where
21 Jul 2021	CLASS II	Signa Premier recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
21 Jul 2021	CLASS II	Signa Artist, Nuclear Magnetic Resonance Imaging System recalled	GE Healthcare	Device Malfunction	WI
21 Jul 2021	CLASS II	Discovery MR750w 3.0T recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
21 Jul 2021	CLASS II	1.5T Signa HDxt (HD28) MR System recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
21 Jul 2021	CLASS II	Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System recalled	GE Healthcare	Device Malfunction	WI
21 Jul 2021	CLASS II	Signa MR380, Nuclear Magnetic Resonance Imaging System recalled	GE Healthcare	Device Malfunction	WI
21 Jul 2021	CLASS II	Signa MR355, Signa MR360, Nuclear Magnetic Resonance Imaging System recalled	GE Healthcare	Device Malfunction	WI
21 Jul 2021	CLASS II	Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System recalled	GE Healthcare	Device Malfunction	WI
21 Jul 2021	CLASS II	Discovery MR750 3.0T recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
21 Jul 2021	CLASS II	Signa Creator, Signa Explorer recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
21 Jul 2021	CLASS II	Signa Architect recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
21 Jul 2021	CLASS II	Signa Pioneer recalled by GE Healthcare	GE Healthcare	Device Malfunction	WI
21 Jul 2021	CLASS II	Signa Voyager, Nuclear Magnetic Resonance Imaging System recalled	GE Healthcare	Device Malfunction	WI

More recalls from GE Healthcare

All 512

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	Signa Premier systems recalled by GE Healthcare	GE Healthcare	Other	Nationwide
11 Mar 2026Device	CLASS II	Centricity Universal Viewer Zero Footprint Client recalled	GE Healthcare	Device Malfunction	Nationwide
24 Dec 2025Device	CLASS II	GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological recalled	GE Healthcare	Device Malfunction
9 Apr 2025Device	CLASS II	Centricity Pacs-iw (Pacs-iw) recalled by GE Healthcare	GE Healthcare	Other	IL
9 Apr 2025Device	CLASS II	Centricity Pacs-iw with Universal Viewer recalled by GE Healthcare	GE Healthcare	Other	IL

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All 13,778

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16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide