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FDA (Device enforcement)Recalled 2020-08-14closedclass ii

GE Healthcare, LLC: Discovery NM670 Pro Model # H3100XB

Is my product affected?

Discovery NM670 Pro Model # H3100XB

  • UPC 082426210033
  • UPC 082426120037
  • UPC 082426120039
  • UPC 082426290010
  • UPC 082426180017
  • UPC 082426130053
  • UPC 082426150044
  • UPC 082426160065

Check against the official notice below — it lists the full affected range.

What happened

GE Healthcare, LLC has recalled nine Discovery NM670 Pro nuclear medicine imaging systems (Model # H3100XB) distributed across multiple locations in the United States and internationally. The recall was initiated because rotor bearing screws were found to be loose on the detector component of these systems. The affected units have specific serial numbers ranging from PRGX52001 through PRGX52009, with corresponding System IDs provided for identification purposes.

The recalled systems were distributed throughout the United States (including states such as Arkansas, Connecticut, Florida, Georgia, and others) and to numerous countries including Canada, Japan, the United Kingdom, Germany, France, and others. The source does not specify what remedy or corrective action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Rotor bearing screws were found loose on detector.

Details from the source

Reason for recall: Rotor bearing screws were found loose on detector. 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 Quantity: 9 units Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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