Philips 5-Lead Set — Class II medical device recall Z-2495-2019
Terminated recall by Philips North America, LLC, reported 2019-09-18, distributed nationwide. The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified. wh
| Recall number | Z-2495-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2019-07-19 |
| Classified | 2019-09-09 |
| Reported by FDA | 2019-09-18 |
| Terminated | 2020-06-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE |
| Lot numbers | 03/18, 05/18, 06/18 |
| Model numbers | 989803173131 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2495-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.