Philips North America, LLC 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Philips North America, LLC
Lot Codes / Batch Numbers
Lot codes: 03/18, 05/18 and 06/18
Products Sold
Lot codes: 03/18, 05/18 and 06/18
Philips North America, LLC is recalling Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Singl due to 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 performanc. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Philips sent a Customer Information letter dated July 2019 to affected customers. The letter identified the affected product, problem and actions to betaken. Customers were instructed to: 1. To identify all affected limb lead sets. 2. To fill-out, sign and send a reply form that is provided. 3. To discard affected limb lead sets following approved medical waste disposal methods per facility and/or local regulations. 4. Do not return any affected product to Philips if you need any further information or support concerning this issue, please contact your local Philips representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026