Z-2995-2020Class II

NM 830 Model # H3910AC

Name: Z-2995-2020 NM 830 Model # H3910AC
Creator: GE Healthcare, LLC
Published: 2020-08-14
License: https://open.fda.gov/license/

GE Healthcare / initiated 2020-08-14 / Terminated

FDA source

GE Healthcare, LLC began a recall of NM 830 Model # H3910AC on 2020-08-14. FDA classified it as Class II and gives the reason as "Rotor bearing screws were found loose on detector". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2995-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-14
Posted: 2020-09-21
Terminated: 2021-05-06
Recalling firm: GE Healthcare
Product: NM 830 Model # H3910AC
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Rotor bearing screws were found loose on detector.
FDA root cause: Use error
Action: GE Healthcare issued an Urgent Medical device correction notification on August 14, 2020. It states the following: 1. GE Healthcare will inspect and, if required, correct all affected products at no cost to you. 2. A GE Healthcare representative will contact you to arrange for the correction 3. Please complete the acknowledgement form and return it to GE Healthcare promptly upon receipt and no later than 30 days from receipt to [email protected] If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 25 units
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2995-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2991-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-21
Z-2992-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-21
Z-2993-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-21
Z-2994-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-21
Z-2995-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-21
Z-2996-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-21
Z-2997-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-21
Z-2998-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-21

Product code KPS

K111445Class IIDiscovery Nm 630GE Healthcare / cleared 2011-06-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)