B-K Medical A/S: Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

Hazard

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.

Details from the source

Reason for recall: 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. 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), Kuwai Quantity: 1697 units Lot/code info: 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, 5010935,

UPC codes

05704916001285

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.