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ECG Cables and Leadsets

Philips Medical Systems Hsg · Model 5-LEAD SET, DISPOSABLE, CHEST, IEC · UDI-DI 20884838075751

DSA Prescription

510(k) clearances

629

Adverse events (17 deaths)

Recalls

139

Facilities

Description

Philips Single-Patient-Use Disposable ECG Lead Sets are intended for use only by trained healthcare professionals for measurement of a patients ECG for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. These Philips lead sets are intended for short-term use only (average patient stay of 5 days). Average lifetime of 5 days for disposable products.

Recalls

Date	Firm	Reason
2025-01-21	Physio-Control, Inc.	Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
2022-02-03	Volcano Corp	Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. T
2019-08-01	GN Otometrics	The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.
2019-07-19	Philips North America, LLC	The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified. which may prevent or impede the performance of I 2-Lead ECG measurements
2019-05-10	GE Healthcare, LLC	ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
2019-05-10	GE Healthcare, LLC	ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
2019-05-10	GE Healthcare, LLC	ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
2019-05-10	GE Healthcare, LLC	ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
2019-05-10	GE Healthcare, LLC	ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
2014-03-05	Remington Medical Inc.	Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically, the polarity for the black chuck in the picture is wrong. It shows (+), but shoul

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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.