CLASS II Device recall · Reported 30 Sep 2020 · FDA Enforcement Report

Discovery NM670 Pro recalled by GE Healthcare

GE Healthcare is recalling Discovery NM670 Pro, distributed in 25 states. The recall was initiated on 14 Aug 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial # PRGX52001 System ID: NMPRGX52001 Serial # PRGX52003 System ID: 082426210033 Serial # PRGX52008 System ID: 082426120037 Serial # PRGX52005 System ID: 082426120039 Serial # PRGX52007 System ID: 082426290010 Serial # PRGX52004 System ID: 082426180017 Serial # PRGX52009 System ID: 082426130053 Serial # PRGX52002 System ID:082426150044 Serial # PRGX52006 System ID:082426160065

Quantity recalled9 units

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-2997-2020
FDA event ID: 86337
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 14 Aug 2020
FDA classified: 21 Sep 2020
Reported: 30 Sep 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Aug 2020	Recall initiated by company
21 Sep 2020	Classified by FDA	+38 days
30 Sep 2020	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

Rotor bearing screws were found loose on detector.

Product as listed by the FDA

Discovery NM670 Pro Model # H3100XB

Where it was distributed

USA : AR CT FL GA IL KS KY LA MA MD MI MN MO NE NJ NV NY OH OK RI SC TN TX VA VT WA WI OUS: ARGENTINA AUSTRIA BELGIUM BRAZIL Canada CHINA FRANCE GERMANY GREECE INDIA ISRAEL ITALY JAPAN Korea (Republic of) NETHERLANDS NORWAY PANAMA POLAND PORTUGAL Russia SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM VIETNAM

Arkansas Connecticut Florida Georgia Illinois Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Nebraska New Jersey Nevada New York Rhode Island South Carolina Tennessee

Questions about this recall

Why was it recalled?

Rotor bearing screws were found loose on detector.

Which lots are affected?

Serial # PRGX52001 System ID: NMPRGX52001 Serial # PRGX52003 System ID: 082426210033 Serial # PRGX52008 System ID: 082426120037 Serial # PRGX52005 System ID: 082426120039 Serial # PRGX52007 System ID: 082426290010 Serial # PRGX52004 System ID: 082426180017 Serial # PRGX52009 System ID: 082426130053 Serial # PRGX52002 System ID:082426150044 Serial # PRGX52006 System ID:082426160065

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

7 other products · FDA event 86337

This product is part of a recall event; the main page for the event is NM/CT recalled by GE Healthcare.

Reported	Class	Recall	Company	Reason	Where
30 Sep 2020	CLASS II	NM/CT recalled by GE Healthcare	GE Healthcare	Other	25 states
30 Sep 2020	CLASS II	Discovery NM recalled by GE Healthcare	GE Healthcare	Other	25 states
30 Sep 2020	CLASS II	NM/CT 870 DR recalled by GE Healthcare	GE Healthcare	Other	25 states
30 Sep 2020	CLASS II	Nm/CT 870 Czt recalled by GE Healthcare	GE Healthcare	Other	25 states
30 Sep 2020	CLASS II	NM 830 Model # H3910AC recalled by GE Healthcare	GE Healthcare	Other	25 states
30 Sep 2020	CLASS II	Discovery 670 DR recalled by GE Healthcare	GE Healthcare	Other	25 states
30 Sep 2020	CLASS II	Nm/CT 860, Spect/CT recalled by GE Healthcare	GE Healthcare	Other	25 states

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

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide