NM/CT 850 Model Number: H3907AD
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-2991-2020
- Quantity
- 25 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 # 85EX67001 System ID: 203789NM850 Serial # 85EX67023 System ID: 813443D850 Serial # 850X61005 System ID: 847618NM850 Serial # 85EX67019 System ID: 773296NM850 Serial # 85EX67021 System ID: 217554NMCT Serial # 85EX67008 System ID: 779696NM850 Serial # 85EY67015 System ID: 504988NM850 Serial # 85EX67017 System ID: 318212NM Serial # 85EX67012 System ID: 781729NM Serial # 85EX67006 System ID: 573814NM2 Serial # 850X61001 System ID: Not Available Serial # 85EX67002 System ID: 419289D850 Serial # 85EX67009 System ID: 513732NM Serial # 85EX67016 System ID: 972969NM Serial # 85EX67004 System ID: 571472NM850 Serial # 85EX67010 System ID: 804289NM850A Serial # 85EX67011 System ID: 804281NM850A Serial # 85EX67005 System ID: 715717NMCT Serial # 85EX67018 System ID: 414219NMCT Serial # 85EX67013 System ID: 920456NM Serial # 850X61004 System ID: 030601NU06 Serial # 85EX67007 System ID: A5116074 Serial # 850X61002 System ID: NS0001 Serial # 85EX67003 System ID: PL1692NM05 Serial # 85EX67014 System ID: PPR59076
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.