Boston Scientific Corporation recalls CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel nu…

Recall date

June 2, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1817-2015

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

No US distribution. Worldwide Distribution to the countries of : Austria, Belgium, France, Germany, Great Britain, Greece, Italy, Netherlands, Poland, Romania, South Africa, Spain, Switzerland and Turkey.

Why it was recalled

Boston Scientific has received complaints indicating that, when using the blood pressure (BP) channels on the CLEARSIGN II Amplifier, the surface Electrocardiogram (ECG) channels become over-written to a variable degree, with the result that it appears shifted from baseline on the system's output screen. This may, in turn, manifest as an uninterpretable ECG signal in the affected channel.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as follows: Material number: H30120020210 - 40 Channel CLEARSIGN II Amplifier, catalog number 2002021; Material number: H30120020220 80 Channel CLEARSIGN II Amplifier, catalog number 2002022; Material number: H30120020230 120 Channel CLEARSIGN II Amplifier, catalog number 2002023; Material number: H30120020240 160 Channel Clearsign II Amplifier, catalog number 2002014. The CLEARSIGN II Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the LABSYSTEM PRO EP Recording System) that can record and display the information