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
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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