FDA recall Z-2993-2020

GE Healthcare, LLC · Class II · device

Product

NM/CT 870 CZT Model # H3906CW

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

Key facts

Status
Terminated
Initiation date
2020-08-14
Report date
2020-09-30
Termination date
2021-05-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2993-2020