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LABSYSTEM™ PRO
BOSTON SCIENTIFIC CORPORATION · Model M0042001267R0 · UDI-DI 08714729883302
DRQ
Prescription
10
510(k) clearances
51
Adverse events
1
Recalls
36
Facilities
Description
CLEARSIGN™ Amplifier For LABSYSTEM™ PRO EP Recording System, 80 Channels
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-06-02 | Boston Scientific Corporation | Boston Scientific has received complaints indicating that, when using the blood pressure (BP) channels on the CLEARSIGN II Amplifier, the surface Electrocardiogram (ECG) channels b |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.