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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, AAMIsee related information
Date Initiated by FirmJuly 19, 2019
Create DateSeptember 09, 2019
Recall Status1 Terminated 3 on June 03, 2020
Recall NumberZ-2495-2019
Recall Event ID 83560
510(K)NumberK110287 
Product Classification Cable, transducer and electrode, patient, (including connector) - Product Code DSA
ProductPhilips 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
FEI Number 1218950
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information ContactPhilips 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
ActionPhilips 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 Commerce280 boxes ( 5600 leadsets)
DistributionWorldwide Distribution - US Nationwide State KY AZ CA UT OH NY SC CO FL IN TX ND KS GA Canada Germany
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DSA
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