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
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