CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System — Class II medical device recall Z-1817-2015
Terminated recall by Boston Scientific Corporation, reported 2015-06-24. Boston Scientific has received complaints indicating that, when using the blood pressure (BP) channels on the
| Recall number | Z-1817-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Lowell, MA, United States |
| Recall initiated | 2015-06-02 |
| Classified | 2015-06-18 |
| Reported by FDA | 2015-06-24 |
| Terminated | 2016-10-26 |
| Countries outside the US | AT, BE, CH, DE, ES, FR, GB, GR, IT, NL, PL, RO, TR, ZA |
| Quantity | 43 units |
| Lot numbers | EPYL0031, EPYL0032, EPYL0033, EPYL0034, EPYL0035, EPYL0036, EPYL0037, EPYL0038, EPYL0039, EPYL0080, EPYL0082, EPYL0083, EPYL0118, EPZA0061, EPZA0062, EPZA0063, EPZA0064, EPZA0072, EPZA0073, EPZA0074, EPZA0079, EPZA0080, EPZB0043, EPZB0049, EPZB0050, EPZB0051, EPZB0052, EPZB0056, EPZB0057, EPZB0058, EPZB0059, EPZB0065, EPZB0066, EPZB0067, EPZB0085, EPZB0116, EPZB0117, EPZB0118, EPZB0119, EPZC0018 and 17 more |
| Model numbers | 2002014, 2002021, 2002022, 2002023, 2002024 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1817-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.