Recall Z-2495-2019— Philips North America, LLC
Class II · Terminated
Class II FDA medical device recall by Philips North America, LLC, initiated 2019-07-19, terminated 2020-06-03. It names one FDA 510(k) clearance: K110287. 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: 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..
- Recalling firm
- Philips North America, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-19
- Terminated
- 2020-06-03
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.