FDA Device recall Z-1817-2015
CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08
- FDA Device
- Class II
- terminated
- Published 2015-06-24
On 2015-06-24 the FDA classified a Class II recall of CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08 by Boston Scientific, citing boston Scientific has received complaints indicating that, when using the blood pressure (BP) channels on the CLEARSIGN II Amplifier, the surface Electrocardiogram (ECG) channels….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1817-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-02 |
| Published | 2015-06-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
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
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.
Identifiers
| code_info | Catalog number 2002021: lot numbers: EPYL0080, EPYL0118, EPZA0061, EPZA0072, EPZA0073, EPZA0074, EPZB0043, EPZC0019, E…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1817-2015%22
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