Recall Z-1817-2015 ยท DRQ Amplifier And Signal Conditioner, Transducer Signal
Boston Scientific Corporation
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 Ampli
| Date | Jun 18, 2015 (initiated Jun 2, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 Verifica |
| Quantity | 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 Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150235 | CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIG Boston Scientific Corporation, Apr 22, 2015 |