Z-2997-2020Class II

Discovery NM670 Pro Model # H3100XB

Name: Z-2997-2020 Discovery NM670 Pro Model # H3100XB
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 NM670 Pro Model # H3100XB 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-2997-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-14
Posted: 2020-09-21
Terminated: 2021-05-06
Recalling firm: GE Healthcare
Product: Discovery NM670 Pro Model # H3100XB
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: 9 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 # 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2997-2020
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)