Class II U.S. Food and Drug Administration

B-K Medical A/S bk3500 Ultrasound System w/battery recall: GE HealthCare has become aware that the Instructions for Use within the user

Recall published 12 months ago

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 hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0439-2026
Published
November 12, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
B-K Medical A/S
Product type
Medical devices
Units affected
124 units
Distribution
Nationwide
Made in
Denmark
Lot / code info
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, 5009339, 5009340, 5009722, 5013052, 5013067, 5008617, 5007733, 5009361, 5008995, 5009357, 5008012, 5009732, 5006923, 5007592, 5009019, 5009723, 5009729, 5009003, 5009005, 5008271, 5009730, 5007422, 5009747, 5007424, 5008265, 5008534, 5009012, 5009740, 5008541, 5006928, 5009737, 5009347, 5009348, 5009349, 5009363, 5009720, 5008625, 5009733, 5009360, 5009013, 5009014, 5007429, 5007742, 5009719, 5013351, 5009011, 5009017, 5009727, 5013069, 5008262, 5009020, 5007850, 5009335, 5009336, 5007609, 5009004, 5007608, 5007857, 5009338, 5009725, 5009351, 5009724, 5008147, 5009350, 5009352, 5008623, 5009738, 5008996, 5008274, 5013610, 5009341, 5013591, 5009742, 5008551, 5009741, 5008053, 5008269, 5008018, 5008267, 5009010, 5009739, 5013423, 5007426, 5007611, 5007855, 5009745, 5009734, 5007738, 5008533, 5008014, 5008270, 5008536, 5009007, 5008545, 5008281, 5009342, 5009343, 5009728, 5009735, 5009736, 5009746, 5013319, 5013325, 5013586, 5008626.
UPC codes
05704916000264

Products covered by this recall

bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic

Check your product

The notice names 7 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 05704916000264

Model or item number

On the rating label, the box or the instruction sheet.

  • 2300-41

Serial number

On the rating plate, often next to the date of manufacture.

  • 5009743
  • 5009345
  • 5009346
  • 5009353
  • 50075

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

B-K Medical A/S — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: B-K Medical A/S — Mileparken 34, Herlev

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was B-K Medical A/S medical devices 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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 05704916000264; model number 2300-41. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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