Health product recall

BLOOD MONITORING UNIT 40 (BMU 40) (2020-09-22)

Starting date:
September 22, 2020
Posting date:
October 16, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-74117



Last updated:
2020-10-15

Affected Products

BLOOD MONITORING UNIT 40 (BMU 40)

Reason

The printed circuit board (PCBA Connector) of the BMU40 was designed with a short creepage distance. This PCBA Connector is positioned in the inner and backside of the metal enclosure of the BMU40. This may lead to shock, loss of data, or delay of use. Maquet Cardiopulmonary GmbH has not received any reports of serious injuries or death due to the malfunction of the PCBA Connector.

Affected products

BLOOD MONITORING UNIT 40 (BMU 40)

Lot or serial number

90002058

90002102

90002103

90002107

90002111

Model or catalog number

BMU40

Companies
Manufacturer

Maquet Cardiopulmonary GmbH

Kehler Str. 31

Rastatt

76437

GERMANY