Recall Z-2997-2020 ยท KPS System, Tomography, Computed, Emission
GE Healthcare, LLC
Discovery NM670 Pro Model # H3100XB
| Date | Aug 14, 2020 |
| Status | Terminated |
| Reason | Rotor bearing screws were found loose on detector. |
| Root cause | Use error |
| Action | 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 S |
| Quantity | 9 units |
| 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 T |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093514 | DISCOVERY MODEL NM/CT 670 Ge Medical Systems F.I. Haifa, Dec 10, 2009 |