bk3500 ultrasound systems recalled over incomplete battery safety instructions
B-K Medical is recalling 124 bk3500 ultrasound systems 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 bk3500 Ultrasound System with battery, model 2300-41, 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 124 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
- bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
- Manufacturer
- B-K Medical A/S
- Affected units
- 124
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: 5009743
- 5009345
- 5009346
- 5009353
- 5007595
- 5007746
- 5009358
- 5009726
- 5009021
- 5008627
- 5008542
- 5008280
- 5008994
- 5007594
- 5008019
- 5009344
- 5009000
- 5009001
- 5009002
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by B-K Medical A/S under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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