FDA-Device2020-09-30Class II

NM/CT 870 DR Model # H3100AS

GE Healthcare, LLC
Hazard

Rotor bearing screws were found loose on detector.

Sold states
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
Affected count
31 units
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
NM/CT 870 DR Model # H3100AS

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2998-2020

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