medical Class II Updated 2020-11-18

Maquet Cardiovascular Us Sales, Llc recalls Blood Monitoring Unit (BMU 40), model no. 701040852 - Produc

Recalled Product

Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (pO2), temperature (TArt and TVen), oxygen saturation (SO2), hemoglobin (Hb) and hematocrit (Hct).

Hazard / Issue

The Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, third edition). The BMU 40 units affected by this recall were designed with a short creepage distance of 1.8 mm between the two distinct and proximal areas on the printed circuit board (PCB) where as the standard requires a creepage distance of 4 mm.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Serial numbers 90002022 90002134 90002163 90002187 90002276 90002297 90002023 90002135 90002164 90002188 90002277 90002298 90002024 90002136 90002168 90002191 90002279 90002302 90002029 90002137 90002170 90002194 90002280 90002306 90002047 90002140 90002172 90002195 90002281 90002312 90002112 90002143 90002181 90002196 90002287 90002313 90002123 90002144 90002183 90002210 90002289 90002124 90002160 90002184 90002212 90002293 90002133 90002161 90002185 90002273 90002296

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