Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0437-2026 — UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

U.S. FDA — Device Enforcement · Denmark · 2025-10-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0437-2026
Date of alert
2025-10-09
Country / jurisdiction
Denmark
Risk level
Class II
Risk type
recall
Brand
B-K Medical A/S
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05704916000264
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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