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U.S. Department of Health and Human Services

Class 2 Device Recall Philips 5Lead Set, Disposable, Bedside, AAMI

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  Class 2 Device Recall Philips 5Lead Set, Disposable, Bedside, AAMI see related information
Date Initiated by Firm July 19, 2019
Create Date September 09, 2019
Recall Status1 Terminated 3 on June 03, 2020
Recall Number Z-2495-2019
Recall Event ID 83560
510(K)Number K110287  
Product Classification Cable, transducer and electrode, patient, (including connector) - Product Code DSA
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
Code Information Lot codes: 03/18, 05/18 and 06/18
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Philips Customer Services
800-722-9377
Manufacturer 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 2		 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 in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DSA and Original Applicant = PHILIPS MEDICAL SYSTEMS
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