NM/CT 870 DR Model # H3100AS
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-2998-2020
- Quantity
- 31 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 # 870X64001 System ID: 030020NU06 Serial # 870X64004 System ID: M4018555 Serial # 870X64012 System ID: X634445001 Serial # 870X64007 System ID: V2728113 Serial # 870X64009 System ID: M4016255 Serial # 870X64026 System ID: M40230109 Serial # 870X64017 System ID: M40240121 Serial # 870X64018 System ID:M40240121 Serial # 870X64015 System ID:M40345223 Serial # 870X64016 System ID:499221NU01 Serial # 870X64031 System ID:083049209623319 Serial # 870X64014 System ID:IL1028NM41 Serial # 870X64022 System ID: A5173220 Serial # 870X64019 System ID: 0850260167XE6 Serial # 870X64020 System ID: 0850260169 Serial # 870X64025 System ID: EMM0135 Serial # 870X64010 System ID:NM2882PA Serial # 870X64027 System ID: PL0398NM01 Serial # 870X64029 System ID: PL1031NM01 Serial # 870X64030 System ID: PL2190NM01 Serial # 870X64028 System ID: PL0372NM01 Serial # 870X64023 System ID: 600042NM10 Serial # 870X64013 System ID: NP473631 Serial # 870X64021 System ID: G001NU12 Serial # 870X64008 System ID:00669NUC03
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.