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The official notice did not include a photo. Check the product details and identifiers below.
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An official Health Canada notice concerns Fetal spiral electrode. Between September 2012 and September 2021, Philips continued to include a 2007 edition of the IFU with the fetal spiral electrode product. This previous edition did not include the following warning messages in the "warnings" section of the IFU: Reuse may cause degradation of physical or electrical properties, Do not reuse on another patient due to risk of cross-infection the current edition of the of the fetal spiral electrode instructions for use (IFU) is part number 453564380371, September 2012. The previous edition of the IFU is part number 453564065231, July 2007. Recall start date: 2021-11-01 Published 2021-11-19.
What to do now
Contact the manufacturer if you require additional information
Recall number
63618
Official notice
2021-11-19
The hazard
The hazard
Between September 2012 and September 2021, Philips continued to include a 2007 edition of the IFU with the fetal spiral electrode product. This previous edition did not include the following warning messages in the "warnings" section of the IFU: Reuse may cause degradation of physical or electrical properties, Do not reuse on another patient due to risk of cross-infection the current edition of the of the fetal spiral electrode instructions for use (IFU) is part number 453564380371, September 2012. The previous edition of the IFU is part number 453564065231, July 2007. Recall start date: 2021-11-01
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.
Recall Numbers
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Affected products
Product 1
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, Fetal Spiral Electrode.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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