bkActiv ultrasound systems recalled over battery guidance missing from manuals
B-K Medical is recalling 567 Ultrasound System 2300 bkActiv units because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 as a labeling deficiency: the record cites missing instructions rather than a device defect, and states no consequence or reported harm.
Plain-English summary
The Ultrasound System 2300, bkActiv with battery, model 2300-11, is being 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.
The recall covers 567 units, including GTIN 05704916000264, distributed worldwide including nationwide in the United States and to countries including Algeria, Argentina, Australia and Austria. The FDA has classified the action as Class II.
The enforcement record describes the documentation gap without stating a health consequence, and reports no injuries. Sites operating an affected system should follow the firm's instructions.
The recalled product
- Product
- UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
- Manufacturer
- B-K Medical A/S
- Hazard
- incomplete-instructions
- battery-safety
- labeling-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 05704916000264 and pending
- Serial Numbers: 2008018
- 2003427
- 2008941
- 2005905
- 5014230
- 2008447
- 2005014
- 2005669
- 2006518
- 5013628
- 2007486
- 2004009
- 2004033
- 2005897
- 2004848
- 2005428
- 2005443
- 2001579
- 2002735
Distribution
Distributed nationwide across the United States.
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