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Heartstart intrepid monitor defibrillator
Official notice
17 Nov 2023
Last checked
17 Nov 2023
An official Health Canada notice concerns Heartstart intrepid monitor defibrillator. Philips has identified a potential safety and compliance issue: the HeartStart Intrepid Monitor/Defibrillator's service manual does not detail electrical safety test verification methods as required by International Electrotechnical Commission(IEC) requirements for class I devices. The current HeartStart Intrepid service manual does not detail IEC class I electrical safety test verification methods. The lack of this testing does not introduce a failure, but it may prevent a failure from being detected. This could occur when an IEC class I device is tested as a class II device after a servicing event. The issue was identified as the result of a service provider's inquiry. There have been no reports of patient harm. Recall start date: October 19, 2023 Published 2023-11-17.
What to do now
Contact the manufacturer if you require additional information.
Recall number
74608
Official notice
2023-11-17
The hazard
The hazard
Philips has identified a potential safety and compliance issue: the HeartStart Intrepid Monitor/Defibrillator's service manual does not detail electrical safety test verification methods as required by International Electrotechnical Commission(IEC) requirements for class I devices. The current HeartStart Intrepid service manual does not detail IEC class I electrical safety test verification methods. The lack of this testing does not introduce a failure, but it may prevent a failure from being detected. This could occur when an IEC class I device is tested as a class II device after a servicing event. The issue was identified as the result of a service provider's inquiry. There have been no reports of patient harm. Recall start date: October 19, 2023
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Philips, Heartstart Intrepid Monitor Defibrillator.
Source & status
Source & status
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Tier
Category
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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