Recall Z-2495-2019
Philips North America, LLC · initiated July 19, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot codes: 03/18, 05/18 and 06/18
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-2495-2019
- Initiated
- July 19, 2019
- Terminated
- June 3, 2020
- Product code
- DSA – Cable, Transducer And Electrode, Patient, (Including Connector)
- 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
- Recalling firm
- Philips North America, LLC, Andover, MA