NM/CT 870 CZT Model # H3906CW
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-2993-2020
- Quantity
- 15 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 # 87CX63007 System ID: AH0101NM05 Serial # 87CX63008 System ID: 190020NU01 Serial # 87CX63006 System ID: 030240NU11 Serial # 87CX63015 System ID: 705743NM870 Serial # 87CX63014 System ID: 030078NU28 Serial # 87CX63011 System ID: M4184879 Serial # 87CX63003 System ID: M9886873 Serial # 87CX63004 System ID: X171582003 Serial # 87CX63009 System ID: M171582018 Serial # 87CX63010 System ID: UC1796NU01 Serial # 87CX63013 System ID: NO1068MN18 Serial # 87CX63005 System ID: A004NU20 Serial # 87CX63002 System ID: C028NU01 Serial # 87CX63012 System ID: C028NU02 Serial # 87CX63001 System ID: 900010NU12
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.