Recall Z-0788-2019 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE Healthcare, LLC
GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric). Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Uro
| Date | Jan 30, 2019 (initiated Dec 28, 2018) |
| Status | Terminated |
| Reason | Increased temperature in the probe-head surface with LOGIQ P6 Model BT07 and BT09 scanners when used in specific types of scans and with specific probes. |
| Root cause | Device Design |
| Action | The firm disseminated its medical device correction notices by letter on 12/28/2018. The letter recommends discontinuing scanning patients in endocavity, surgical, and neonatal exams and to discontinue the use of E8C, E8CS, BE9C, BE9CS, 4DE7C, i12L, 8C, 4D8C, 7S, 5S, and 5Sp probes. |
| Quantity | 1,897 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073297 | GE LOGIQ P6 General Electric Co., Dec 18, 2007 |