GE Healthcare Recalls LOGIQ P6 Ultrasound Scanners Due to Probe Heating
GE Healthcare is recalling 1,897 LOGIQ P6 ultrasound scanners (Models BT07 and BT09) because the probe-head surface can reach increased temperatures during specific scans.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential burn injury from increased temperature) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling 1,897 units of the LOGIQ P6 Premium TruScan Imagining Technology ultrasound scanners, specifically Models BT07 and BT09. The recall was initiated because the probe-head surface of these devices can experience increased temperatures when used in specific types of scans with specific probes.
The affected devices were distributed worldwide. The scanners are intended for use by qualified physicians for various ultrasound evaluations, including fetal, abdominal, pediatric, and cardiac imaging. The source text does not report any specific injuries, illnesses, or fatalities associated with this defect.
Consumers and healthcare facilities should check their device serial numbers against the list provided in the official recall notice. If a device is affected, users should contact GE Healthcare for instructions on corrective actions or repairs.
The recalled product
- 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…
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 1,897
Distribution
Distribution scope not specified by the agency.
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