CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel num

FDA device recall Z-1817-2015 · posted 2015-06-18 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

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.

Action taken

Boston Scientific sent an Important Field Safety Notification letter to all affected customers beginning June 3, 2015, by 24 hour overnight delivery. The letter identified the product the problem and the action needed to be taken by the customer. INSTRUCTIONS: 1. Please read carefully the Field Safety Notice letter and immediately post this information in a visible location near the product to ensure it is easily accessible to all users of the device. 2. Please complete the attached Verification Form even if you do not have any product to return. 3. When completed, please return the Verification Form to your local Boston Scientific Office to the attention of Customer_Service_Fax_Number on or before DATE 2015. 4. If you have products to return, and once a loaner unit is available, a Boston Scientific representative will coordinate with you to package the product being returned using a special shipping container. Your Competent Authority is being notified of this Field Safety Notice. We regret any inconvenience that this action may cause and we appreciate your understanding as we take action to ensure patient safety and customer satisfaction. If you have any questions or would like assistance with this Field Safety Notice, please contact your local Sales Representative. For further questions please call (978)-805-3200

Root cause

Software design

Status

Terminated

Product code

DRQ

Quantity affected

43 units

Distribution

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 Tur

Date initiated

2015-06-02

Date posted

2015-06-18

Date terminated

2016-10-26

Location

Lowell, MA

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