Recalls / —

—#183468

Product

Discovery NM670 Pro Model # H3100XB

FDA product code

KPS — System, Tomography, Computed, Emission

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K093514

Affected 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

Why it was recalled

Rotor bearing screws were found loose on detector.

Root cause (FDA determination)

Use error

Action the firm took

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 nm.fmi40890.responses@ge.com 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.

Recalling firm

Firm

GE Healthcare, LLC

Address

3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern

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

Timeline

Recall initiated

2020-08-14

Terminated

2021-05-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #183468. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.