Z-2996-2020Class II

Discovery 670 DR Model # H3100BT

Name: Z-2996-2020 Discovery 670 DR Model # H3100BT
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 Discovery 670 DR Model # H3100BT 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-2996-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-14
Posted: 2020-09-21
Terminated: 2021-05-06
Recalling firm: GE Healthcare
Product: Discovery 670 DR Model # H3100BT
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: 20 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 # DRGX56002 System ID: 4445804NM11 Serial # DRGX56005 System ID: 614CVA6702CT Serial # DRGX56004 System ID: 403343D670A Serial # DRGX56017 System ID: 110002NU06 Serial # DRGX56018 System ID: X7410502 Serial # DRGX56003 System ID: 403438NU02 Serial # DRGX56010 System ID: UC4097NU02 Serial # DRGX56008 System ID: 826251NU01 Serial # DRGX56007 System ID: H2101NUC35 Serial # DRGX56006 System ID: 083026063363718 Serial # DRGX56011 System ID: 083026281900218 Serial # DRGX56009 System ID: 083049206531619 Serial # DRGX56021 System ID: 083026603411518 Serial # DRGX56019 System ID: A220806209 Serial # DRGX56012 System ID: STD01300 Serial # DRGX56014 Not Available Serial # DRGX56016 System ID: GEE34069 Serial # DRGX56020 System ID: DEL26498 Serial # DRGX56022 System ID: DE6588153 Serial # DRGX56015 System ID: 0853260202

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2996-2020
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)