Z-2992-2020 Class II Terminated
FDA device recall Z-2992-2020 was initiated by GE Healthcare, LLC on August 14, 2020 and is designated Class II. Reason for recall: Rotor bearing screws were found loose on detector. The recall status is terminated (terminated May 6, 2021). Affected quantity: 4 units.
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