—#175736

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

FDA product code: DSA — Cable, Transducer And Electrode, Patient, (Including Connector)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K110287
Affected lot / code info: Lot codes: 03/18, 05/18 and 06/18

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide State KY AZ CA UT OH NY SC CO FL IN TX ND KS GA Canada Germany

Timeline

Recall initiated: 2019-07-19
Terminated: 2020-06-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175736. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.