Z-2992-2020 Class II Terminated

Recalled by GE Healthcare, LLC — Waukesha, WI

Recall Details

Product Type
Devices
Report Date
September 30, 2020
Initiation Date
August 14, 2020
Termination Date
May 6, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 units

Product Description

NM/CT 860, SPECT/CT

Reason for Recall

Rotor bearing screws were found loose on detector.

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

Code Information

Serial # 850X61003 , System ID: 401793860NM, Model # H3908AD Serial # 860X62001 , System ID:E6843969, Model # H3908AE Serial # 870X64005 , System ID:HC4387NU05, Model # H3100AS Serial # 860X62002 , System ID:PL0399NM01, Model # H3100AS