Recall Z-0788-2019— GE Healthcare, LLC

Name: FDA recall Z-0788-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-28

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2018-12-28, terminated 2020-10-05. It names one FDA 510(k) clearance: K073297. Product: 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).. 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..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-12-28
Terminated: 2020-10-05
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K073297 — GE LOGIQ P6General Electric Co.·cleared 2007-12-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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).

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.