FDA-Device2019-09-18Class II
Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration
Philips North America, LLC
Hazard
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.
Sold states
Worldwide Distribution - US Nationwide State KY AZ CA UT OH NY SC CO FL IN TX ND KS GA Canada Germany
Affected count
280 boxes ( 5600 leadsets)
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2495-2019Don't want to check this manually?
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