GE HEALTHCARE LOGIQ P6 Premium TruScan — Class II medical device recall Z-0788-2019
Terminated recall by GE Healthcare, LLC, reported 2019-02-06. Increased temperature in the probe-head surface with LOGIQ P6 Model BT07 and BT09 scanners when used in specif
| Recall number | Z-0788-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2018-12-28 |
| Classified | 2019-01-30 |
| Reported by FDA | 2019-02-06 |
| Terminated | 2020-10-05 |
| Quantity | 1,897 units |
| Model numbers | 099566SU2, 099567SU0, 101076SU8, 101077SU6, 101078SU4, 101079SU2, 101081SU8, 101082SU6, 101083SU4, 101084SU2, 101085SU9, 101086SU7, 101087SU5, 101088SU3, 101089SU1, 101090SU9, 101793SU8, 101839SU9, 101840SU7, 101841SU5, 101842SU3, 101843SU1, 101844SU9, 101845SU6, 101846SU4 and 475 more |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0788-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.