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).
FDA Recall Z-0788-2019 · Posted 2019-01-30
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeIYN
Date Initiated2018-12-28
Date Terminated2020-10-05
Product Quantity1,897 units
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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