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; Urology (including prostate); Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, vascular).
Recall
- Recall Number
- Z-0788-2019
- Event Number
- 81937
- Firm
- GE Healthcare, LLC
- FEI Number
- 2126677
- Product Code
- IYN
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- December 28, 2018
- Posted
- January 30, 2019
- Terminated
- October 5, 2020
- Address
- 3000 N Grandview Blvd, Waukesha, WI, 53188-1615
Description
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; Urology (including prostate); Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, vascular).
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.
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.
Worldwide distribution.
1,897 units