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
Reported: September 18, 2019 Initiated: July 19, 2019 #Z-2495-2019
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.
Details
- Recalling Firm
- Philips North America, LLC
- Units Affected
- 280 boxes ( 5600 leadsets)
- Distribution
- Worldwide Distribution - US Nationwide State KY AZ CA UT OH NY SC CO FL IN TX ND KS GA Canada Germany
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Philips North America, LLC. Units affected: 280 boxes ( 5600 leadsets).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2019. Severity: Moderate. Recall number: Z-2495-2019.
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