CLASS II Device recall · Reported 21 Jun 2017 · FDA Enforcement Report

Discovery NM/CT 570c X-ray system recalled by GE Healthcare

GE Healthcare is recalling Discovery NM/CT 570c X-ray system, distributed nationwide in the US. The recall was initiated on 19 May 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesn/a

Quantity recalled10,884

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-2196-2017
FDA event ID: 77377
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 19 May 2017
FDA classified: 12 Jun 2017
Reported: 21 Jun 2017
Type: FDA Mandated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

19 May 2017	Recall initiated by company
12 Jun 2017	Classified by FDA	+24 days
21 Jun 2017	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

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Product as listed by the FDA

GE Healthcare Discovery NM/CT 570c X-ray system

Where it was distributed

Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Which lots are affected?

n/a

Where was it sold?

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

15 other products · FDA event 77377

This product is part of a recall event; the main page for the event is Optima CT520 X-ray system recalled by GE Healthcare.

Reported	Class	Recall	Company	Reason	Where
21 Jun 2017	CLASS II	Optima CT520 X-ray system recalled by GE Healthcare	GE Healthcare	Other	Nationwide
21 Jun 2017	CLASS II	lnnova IGS 540 ACT X-ray system recalled by GE Healthcare	GE Healthcare	Other	Nationwide
21 Jun 2017	CLASS II	BrightSpeed X-ray system recalled by GE Healthcare	GE Healthcare	Other	Nationwide
21 Jun 2017	CLASS II	Discovery NM/CT recalled by GE Healthcare	GE Healthcare	Other	Nationwide
21 Jun 2017	CLASS II	Discovery Ml DR X-ray system recalled by GE Healthcare	GE Healthcare	Other	Nationwide
21 Jun 2017	CLASS II	Optima CT540 X-ray system recalled by GE Healthcare	GE Healthcare	Other	Nationwide
21 Jun 2017	CLASS II	Discovery IQ X-ray system recalled by GE Healthcare	GE Healthcare	Other	Nationwide
21 Jun 2017	CLASS II	Optima CT580 recalled by GE Healthcare	GE Healthcare	Other	Nationwide
21 Jun 2017	CLASS II	LightSpeed VCT X-ray system recalled by GE Healthcare	GE Healthcare	Other	Nationwide
21 Jun 2017	CLASS II	Lightspeed RT16 X-ray system recalled by GE Healthcare	GE Healthcare	Other	Nationwide
21 Jun 2017	CLASS II	Discovery Ml X-ray system recalled by GE Healthcare	GE Healthcare	Other	Nationwide
21 Jun 2017	CLASS II	Discovery NM/CT 670 CZT X-ray system recalled by GE Healthcare	GE Healthcare	Other	Nationwide
21 Jun 2017	CLASS II	Optima CT660, CT680 X-ray system recalled by GE Healthcare	GE Healthcare	Other	Nationwide
21 Jun 2017	CLASS II	Revolution EVO X-ray system recalled by GE Healthcare	GE Healthcare	Other	Nationwide
21 Jun 2017	CLASS II	Discovery PET/CT 600,610, 690, 710: Optima PET/CT recalled	GE Healthcare	Other	Nationwide

More recalls from GE Healthcare

All 512

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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

Other Imaging Equipment recalls

All 2,336

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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