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

NM 830 Model # H3910AC recalled by GE Healthcare

GE Healthcare is recalling NM 830 Model # H3910AC, 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 # 830X60001 System ID: 479338N830 Serial # 830X60004 System ID: 901227NM1 Serial # 830X60018 System ID: 772468NM830 Serial # 830X60012 System ID: 813315D830 Serial # 830X60011 System ID: 225761NM1 Serial # 830X60014 System ID: 225761NM Serial # 830X60016 System ID: 225761NM Serial # 830X60019 System ID: 573458NM Serial # 830X60023 System ID: 718238D830 Serial # 830X60006 System ID: 716862NM830 Serial # 830X60015 System ID: 585396NM Serial # 830X60003 System ID: 585786NM830 Serial # 830X60025 System ID: 405717NM830 Serial # 830X60021 System ID: 615316NM830 Serial # 830X60017 System ID: 956323NM830 Serial # 830X60002 System ID: 100039NU05 Serial # 830X60022 System ID: 705743DNM830 Serial # 830X60024 System ID: 416898NM830 Serial # 830X60013 System ID: M4040557 Serial # 830X60010 System ID: NS0102 Serial # 830X60020 System ID: NS0101 Serial # 830X60009 System ID: 0850260168 Serial # 830X60005 System ID: 0850260165 Serial # 830X60008 System ID: 0850260166 Serial # 830X60007 System ID: 752030NU01

Quantity recalled25 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-2995-2020
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

NM 830 Model # H3910AC

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 # 830X60001 System ID: 479338N830 Serial # 830X60004 System ID: 901227NM1 Serial # 830X60018 System ID: 772468NM830 Serial # 830X60012 System ID: 813315D830 Serial # 830X60011 System ID: 225761NM1 Serial # 830X60014 System ID: 225761NM Serial # 830X60016 System ID: 225761NM Serial # 830X60019 System ID: 573458NM Serial # 830X60023 System ID: 718238D830 Serial # 830X60006 System ID: 716862NM830 Serial # 830X60015 System ID: 585396NM Serial # 830X60003 System ID: 585786NM830 Serial # 830X60025 System ID: 405717NM830 Serial # 830X60021 System ID: 615316NM830 Serial # 830X60017 System ID: 956323NM830 Serial # 830X60002 System ID: 100039NU05 Serial # 830X60022 System ID: 705743DNM830 Serial # 830X60024 System ID: 416898NM830 Serial # 830X60013 System ID: M4040557 Serial # 830X60010 System ID: NS0102 Serial # 830X60020 System ID: NS0101 Serial # 830X60009 System ID: 0850260168 Serial # 830X60005 System ID: 0850260165 Serial # 830X60008 System ID: 0850260166 Serial # 830X60007 System ID: 752030NU01

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	Discovery NM670 Pro 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	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

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