# FDA recall Z-0788-2019

> **GE Healthcare, LLC** · Class II · device recall initiated 2018-12-28.

## 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.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-0788-2019
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-12-28
- **Report date:** 2019-02-06
- **Termination date:** 2020-10-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0788-2019

## Citation

> AI Analytics. FDA recall Z-0788-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0788-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*