FDA Medical Device Recalls (openFDA)
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 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
- Recall number
- Z-1817-2015
- Recalling firm
- Boston Scientific Corporation
- Product
- 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
- Status
- Terminated
- Initiated
- 2015-06-02
- Posted
- 2015-06-18
- Terminated
- 2016-10-26
- 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 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
- 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.
- Lot, serial or model codes
- Catalog number 2002021: lot numbers: EPYL0080, EPYL0118, EPZA0061, EPZA0072, EPZA0073, EPZA0074, EPZB0043, EPZC0019, EPZC0026, EPZC0027; Catalog number 2002022: lot numbers: EPYL0031, EPYL0032, EPYL0033, EPYL0034, EPYL0035, EPYL0036, EPYL0037, EPYL0038, EPYL0039, EPZA0062, EPZA0063, EPZA0079, EPZA0080, EPZB0049, EPZB0050, EPZB0051, EPZB0052, EPZB0056, EPZB0057, EPZB0058, EPZB0059, EPZB0065, EPZB0066, EPZB0067, EPZB0116, EPZB0117, EPZB0118, EPZC0018, EPZC0020, EPZC0021, EPZC0022, EPZC0023,EPZC0025, EPZD0013, EPZD0014, EPZD0015, EPZD0016, EPZD0017; Catalog number: 2002023: lot numbers: EPYL0082, EPYL0083, EPZA0064, EPZB0085, EPZB0119, EPZC0024, EPZD0018, EPZD0019, EPZD0020; Catalog number: 2002024; lot numbers: EPYL0082, EPYL0083, EPZA0064, EPZB0085, EPZB0119, EPZC0024, EPZD0018, EPZD0019, EPZD0020.
- 510(k) numbers
- ["K150235"]
- PMA numbers
- not on file
- Product code
- DRQ
- Firm FEI
- 1000120754
- Firm city
- Lowell
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28