Z-2495-2019 Class II Terminated
FDA device recall Z-2495-2019 was initiated by Philips North America, LLC on July 19, 2019 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated June 3, 2020). Affected quantity: 280 boxes ( 5600 leadsets).
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2019
- Initiation Date
- July 19, 2019
- Termination Date
- June 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 280 boxes ( 5600 leadsets)
Product Description
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
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - US Nationwide State KY AZ CA UT OH NY SC CO FL IN TX ND KS GA Canada Germany
Code Information
Lot codes: 03/18, 05/18 and 06/18