Maquet BMU 40 Blood Monitoring Units Recalled for Electrical Safety Non-Compliance
Maquet Cardiovascular is recalling 51 Blood Monitoring Units (BMU 40) because the printed circuit boards do not meet IEC electrical safety standards for creepage distance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural electrical safety defect (non-compliance with IEC creepage distance standards) which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 51 units of the Blood Monitoring Unit (BMU 40), model no. 701040852. These devices are used to monitor blood parameters, including oxygen pressure, temperature, saturation, hemoglobin, and hematocrit, during cardiopulmonary bypass or similar procedures with extracorporeal circulation.
The recall was initiated because the Printed Circuit Board Assembly (PCBA) in these units is not in compliance with the IEC 60601-1 standard (third edition). Specifically, the affected units were designed with a short creepage distance of 1.8 mm between two distinct and proximal areas on the printed circuit board, whereas the standard requires a creepage distance of 4 mm.
The affected units were distributed worldwide, including in the United States (AZ, CA, IA, MD, NC, PA, TX, WA, WI) and numerous international locations. Specific serial numbers are listed in the official recall documentation. Healthcare facilities and users should stop using the affected units and contact the manufacturer for instructions on return or replacement.
The recalled product
- 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: parti
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Affected units
- 51
Distribution
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