Recall Z-1257-2019 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare, LLC
Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The main components of the Discovery NM
| Date | Mar 20, 2019 |
| Status | Terminated |
| Reason | During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy. |
| Root cause | Device Design |
| Action | GE Healthcare sent an Urgent Medical Device Correction letter dated March 20, 2019 to affected customers. The letter identified the affected product, problem and actions to be taken. GE Healthcare will inspect and, if required, correct all affected products at no cost to you to ensure that all design redundancies are in place. A GE Healthcare representative will contact you to arrange for the correction. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity | 57 units |
| Distribution | US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111445 | DISCOVERY NM 630 GE Healthcare, Jun 3, 2011 |