Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Ultrasound System 1300 Recalled by B-K Medical A/S Due to GE HealthCare has become aware that the Instructions...

Date: October 9, 2025
Company: B-K Medical A/S
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact B-K Medical A/S directly.

Affected Products

Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

Quantity: 1697 units

Why Was This Recalled?

GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About B-K Medical A/S

B-K Medical A/S has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report