Reported Sep 18, 2019 · Terminated
Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead…
Philips North America, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131
- Product UsagePhilips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration
- Lot codes and dates
- Lot codes
03/1805/18 and 06/18
- Lot codes
- Amount recalled
- 280 boxes ( 5600 leadsets)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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