Recall Z-2495-2019 ยท DSA Cable, Transducer And Electrode, Patient, (Including Connector)
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
| Date | Jul 19, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110287 | PHILIPS ECG LEADWIRE SET Philips Medical Systems, Feb 15, 2011 |