Device product
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
Z-2495-2019
Product summary
- Event
- Event 83560
- Status
- Terminated
- Classification
- Class II
- Quantity
- 280 boxes ( 5600 leadsets)
- Official record key
device-enforcement:Z-2495-2019
Official wording
Reason: 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.
Code information: Lot codes: 03/18, 05/18 and 06/18
Distribution pattern: Worldwide Distribution - US Nationwide State KY AZ CA UT OH NY SC CO FL IN TX ND KS GA Canada Germany
Derived failure modes
-
Unknown
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.