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Recall Observatory FDA recall evidence

Device product

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

Z-0439-2026

October 09, 2025

Class II

Product summary

Firm
B-K Medical A/S
Event
Event 97830
Status
Ongoing
Classification
Class II
Quantity
124 units
Official record key
device-enforcement:Z-0439-2026

Official wording

Reason: 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.

Code information: 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.

Distribution pattern: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Rep, Ecuador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkiye, Ukraine, United Arab Emirates, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.