FDA Device recall Z-0439-2026

bk3500 Ultrasound System w/battery

FDA Device
Class II
ongoing
Published 2025-11-12

On 2025-11-12 the FDA classified a Class II recall of bk3500 Ultrasound System w/battery by B K Medical A S, citing 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-li….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0439-2026
Classification	Class II
Status	ongoing
Initiated	2025-10-09
Published	2025-11-12
Last updated	2026-09-13 11:57 UTC
Company	B K Medical A S
Distribution	US

Product

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

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.

Identifiers

code_info	GTIN 05704916000264 and pending, Serial Numbers: 5009743, 5009345, 5009346, 5009353, 5007595, 5007746, 5009358, 500972… 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, 50097

code_info

GTIN 05704916000264 and pending, Serial Numbers: 5009743, 5009345, 5009346, 5009353, 5007595, 5007746, 5009358, 500972…

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, 50097

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0439-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.