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HolterCare

SCOTTCARE CORPORATION, THE · Model HolterCare · UDI-DI 00856298006169

DQK

510(k) clearances

4,558

Adverse events (53 deaths)

125

Recalls

182

Facilities

Description

The ScottCare HolterCare Analysis System is intended for general hospital or clinical use by medical professionals whenever it is required to assess a patient’s long-term, continuous, ambulatory electrocardiogram (ECG). The long-term ECG is recorded on a digital flash memory Holter recorder. This product allows a trained physician, or other health care professional, to download and analyze the data from the recorder, review it, and produce printed reports. This will enable:  The evaluation of arrhythmias and ischemic attacks.  The reporting of PQRST intervals.  Clinical and epidemiological research studies.  The evaluation of a patient’s response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery).  The evaluation of patients with Pacemakers. The need to record, review, edit, and archive the ambulatory ECG is most commonly encountered in the Cardiology areas of the hospital, or physician’s office, during cardiac assessment of a patient. This device is available for sale to, or on the order of, a licensed physician only and is not intended for any home-use applications.

Recalls

Date	Firm	Reason
2026-07-30	GE Medical Systems Information Technologies Inc	Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.
2026-04-24	GE Medical Systems Information Technologies Inc	Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charr
2025-09-16	Spacelabs Healthcare, Ltd.	Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm
2025-08-11	Merge Healthcare, Inc.	Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error mes
2025-04-11	Centerline Biomedical Inc	Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
2024-09-05	Boston Scientific Corporation	Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c
2024-09-05	Boston Scientific Corporation	Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c
2024-09-05	Boston Scientific Corporation	Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c
2024-09-05	Boston Scientific Corporation	Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c
2024-09-05	Boston Scientific Corporation	Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c

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Data 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.