Recalls / —
—#183467
Product
Discovery 670 DR Model # H3100BT
- FDA product code
- KPS — System, Tomography, Computed, Emission
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K093514
- Affected lot / code info
- Serial # DRGX56002 System ID: 4445804NM11 Serial # DRGX56005 System ID: 614CVA6702CT Serial # DRGX56004 System ID: 403343D670A Serial # DRGX56017 System ID: 110002NU06 Serial # DRGX56018 System ID: X7410502 Serial # DRGX56003 System ID: 403438NU02 Serial # DRGX56010 System ID: UC4097NU02 Serial # DRGX56008 System ID: 826251NU01 Serial # DRGX56007 System ID: H2101NUC35 Serial # DRGX56006 System ID: 083026063363718 Serial # DRGX56011 System ID: 083026281900218 Serial # DRGX56009 System ID: 083049206531619 Serial # DRGX56021 System ID: 083026603411518 Serial # DRGX56019 System ID: A220806209 Serial # DRGX56012 System ID: STD01300 Serial # DRGX56014 Not Available Serial # DRGX56016 System ID: GEE34069 Serial # DRGX56020 System ID: DEL26498 Serial # DRGX56022 System ID: DE6588153 Serial # DRGX56015 System ID: 0853260202
Why it was recalled
Rotor bearing screws were found loose on detector.
Root cause (FDA determination)
Use error
Action the firm took
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.
Recalling firm
- Firm
- GE Healthcare, LLC
- Address
- 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615
Distribution
- 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
Timeline
- Recall initiated
- 2020-08-14
- Terminated
- 2021-05-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #183467. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.