Z-2998-2020Class II

NM/CT 870 DR Model # H3100AS

Name: Z-2998-2020 NM/CT 870 DR Model # H3100AS
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/CT 870 DR Model # H3100AS 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-2998-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-14
Posted: 2020-09-21
Terminated: 2021-05-06
Recalling firm: GE Healthcare
Product: NM/CT 870 DR Model # H3100AS
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: 31 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 # 870X64001 System ID: 030020NU06 Serial # 870X64004 System ID: M4018555 Serial # 870X64012 System ID: X634445001 Serial # 870X64007 System ID: V2728113 Serial # 870X64009 System ID: M4016255 Serial # 870X64026 System ID: M40230109 Serial # 870X64017 System ID: M40240121 Serial # 870X64018 System ID:M40240121 Serial # 870X64015 System ID:M40345223 Serial # 870X64016 System ID:499221NU01 Serial # 870X64031 System ID:083049209623319 Serial # 870X64014 System ID:IL1028NM41 Serial # 870X64022 System ID: A5173220 Serial # 870X64019 System ID: 0850260167XE6 Serial # 870X64020 System ID: 0850260169 Serial # 870X64025 System ID: EMM0135 Serial # 870X64010 System ID:NM2882PA Serial # 870X64027 System ID: PL0398NM01 Serial # 870X64029 System ID: PL1031NM01 Serial # 870X64030 System ID: PL2190NM01 Serial # 870X64028 System ID: PL0372NM01 Serial # 870X64023 System ID: 600042NM10 Serial # 870X64013 System ID: NP473631 Serial # 870X64021 System ID: G001NU12 Serial # 870X64008 System ID:00669NUC03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2998-2020
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

K093514Class IIDiscovery Model Nm/ct 670Ge Medical Systems F.I. Haifa / cleared 2009-12-10

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)