US/CA Recall Hotline: 888-257-7908
US/CA Recall Support Hours: M-F, 8-5 ET
OUS Email Address: philipsleadsets@sedgwick.com
IMPORTANT PRODUCT NOTICE
September 2022
RE: Philips 12-Lead Chest Lead-set (AAMI/IEC)
Dear Customer,
Philips has discovered an issue related to the orientation of the internal wiring of the Philips 12-Lead Chest Leadset (AAMI/IEC).
This Product Notice is intended to inform you about:
1. What the problem is and under what circumstances it can occur
The V1 and V3 leads in the Philips 12-Lead Chest Lead-set (AAMI/IEC) were incorrectly assembled. The internal wiring of V1 and V3 leads being incorrectly positioned (swapped) in the Lead-set hub generates the wrong electrocardiogram (ECG) report and potentially the wrong interpretation of the results on both the 989803151671 (12-Lead Chest Lead-set (AAMI/IEC), Std) and 989803151691 (12-Lead Chest Lead-set (AAMI/IEC), Long). The swapped Lead-set issue is only applicable for the PageWriter TC70, TC50, and TC30 cardiographs.
The Philips 12-Lead Chest Lead-set (AAMI/IEC) is intended to be used in hospitals and physician office environments to transmit electrical signals from electrodes placed on the patient's body to the electrocardiograph (ECG) machine. Upon setting up the electrocardiogram (ECG), there is no indication that the V1 and V3 leads have been swapped. Thus, the user will not know the lead wires are incorrectly assembled until an inaccurate electrocardiogram (ECG) result is produced.
Replacement Lead-sets are currently in production but because COVID-19 has severely disrupted the supply chain globally, these sets are not expected to be available for distribution to customers until mid-February 2023. Once replacement devices are available, customers will be given additional instructions on how to request replacement(s).
2. Affected products and how to identify them
Affected products are identified below in Table 1.
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How to identify Affected products:
Note: We advise you to remove the affected Lead-sets from inventory and discard them. We will not be able to replace your inventory until mid-February of 2023.
To locate the affect products, review the year range on the back of Lead-set hubs labeled 18 to 21 (Image 1). Not all leads within the year code 18 to 21 are affected. To identify the Lead-set between year 18 to 21 that are affected, follow the instructions below. See steps 1-3.
Step 1: Identify Potentially Affected Lead-set
Image 1
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Step 2: Determining if Your Lead-set is Affected
To determine if your leads set is affected, connect the limb leads and only V1 to a simulator. If the Lead-set is good (Normal) V1 will be on and V3 will show which means this lead is not connected. If the leads are reversed (Abnormal) V3 will show on and V1 will show off . All other connections should show off since they are not connected to the simulator. See Image 2 below.
Image 2
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When all the leads are placed, if V1 and V3 are swapped, the system could display a warning message notifying the user of the swapped leads (Image 3).
Image 3
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Step 3: Determining Electrocardiogram (ECG) Results
When looking at the results generated by a normal working electrocardiogram (ECG), the swapped V1 and V3 leads are highly noticeable on V1 and V3 waveform amplitude (Image 4).
Image 4
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3. The actions that you as a customer can take to minimize the effect of the problem
• This communication should be shared with all clinical staff to review and understand.
• Place this Important Product Notice with the documentation of the Philips 12-Lead Chest Lead-set (AAMI/IEC).
• Once a Lead-set is identified as being affected, we advise you to remove the affected Lead-sets from inventory.
• Affected leads should be discarded according to local disposal requirements
4. The actions planned by Philips to correct the problem
• Philips will send a follow up communication in February 2023 at that time we will provide instructions on how to order replacement Lead-sets
If you need any further information or support concerning this issue, please contact your local Philips representative, or call 1‐800‐722‐9377.
Philips regrets any inconvenience caused by this problem.
Sincerely,
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