B-K Medical A/S recalls Ultrasound System 1300

Recalling company

B-K Medical A/S

Product

Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; 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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Oct 9, 2025

Reported

Nov 12, 2025

Distribution

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.

Status

Ongoing

Quantity

1697 units

Lot / codes

1) 1300-21: GTIN 05704916001285 and pending, Serial Numbers: 2002690, 2008466, 2008495, 2006774, 5012683, 5013881, 5012684, 2008725, 2008280, 2004419, 5012980, 2007101, 2009029, 5014333, 2003852, 2002851, 2002142, 2005860, 5013937, 2007188, 2002950, 2003495, 2008470, 5013934, 5013935, 5016211, 2005193, 5014141, 5014514, 5015892, 5012104, 2009012, 2009153, 5012976, 2008185, 2008137, 5012307, 5014139, 2000774, 2006237, 2008144, 5012319, 5014906, 5012789, 5015458, 2006602, 2004379, 2007123, 2008242, 5011353, 2007736, 5014803, 2006235, 5011354, 2002049, 2005281, 5015083, 5015087, 2008527, 5016292, 5016477, 5012055, 5012326, 5015201, 2003658, 2008735, 5011807, 2005450, 2007082, 2009247, 2009142, 2003588, 5016079, 5016301, 2009108, 2008244, 2003721, 2008663, 2008277, 2006691, 5016299, 2008383, 2006881, 5016300, 2006131, 2001918, 2002172, 2005832, 5015218, 2008792, 5011799, 2003137, 5016193, 5016194, 5012310, 5016082, 2008597, 5011479, 2006483, 2001865, 5012954, 5011802, 2002891, 2008356, 2006359, 2004290, 2002824, 2002177, 5011817, 2003597, 2004373, 5013278, 5013126, 5011800, 5011482, 2004264, 2004295, 5015904, 5014266, 2004372, 2005640, 2001433, 2005658, 2006084, 5012545, 2008386, 2002443, 2008578, 2003686, 2002325, 2001425, 2003150, 2003470, 2008080, 2006885, 2004466, 2008586, 2008472, 2000782, 2000821, 2000862, 2000902, 2000906, 2000914, 2000917, 2003502, 2003594, 2003682, 2003854, 2004519, 2008461, 5010293, 5010925, 5010926, 5010927, 5010929, 5010930, 5010933, 5010934, 501093

Company location

Herlev, N/A

Recall type

Voluntary: Firm initiated

Recall number

Z-0436-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0436-2026 in the FDA Enforcement Report. Also see FDA recall press releases.