Reported Nov 12, 2025 · Ongoing
bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
B-K Medical A/S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: B-K Medical A/S · Mileparken 34 · Herlev, N/A · N/A
Is this the product you have?
- bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
- Lot codes and dates
- GTIN 05704916000264 and pending
- Serial Numbers
124 of 124 codes
500974350093455009346500935350075955007746500935850097265009021500862750085425008280500899450075945008019500934450090005009001500900250093395009340500972250130525013067500861750077335009361500899550093575008012500973250069235007592500901950097235009729500900350090055008271500973050074225009747500742450082655008534500901250097405008541500692850097375009347500934850093495009363500972050086255009733500936050090135009014
- Amount recalled
- 124 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- GA
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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