NM/CT 860, SPECT/CT
This recall has been terminated (originally issued August 14, 2020).
- Company
- Ge Healthcare, Llc
- Recall Initiated
- August 14, 2020
- Terminated
- May 6, 2021
- Recall Number
- Z-2992-2020
- Quantity
- 4 units
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
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
Lot / Code Info
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
Root Cause
Use error
Action Taken
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.