OFFICIAL-SOURCE RECALL · AUSTRALIA
ForeSight Oximeter Cable Recall: Classification Class II Reason for the Action
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- ForeSight Oximeter Cable
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Why this product was recalled
Classification Class II Reason for the Action Edwards Lifesciences has identified that during manufacturing, the laterality identification labels may be missing or inaccurately placed on the device. There is potential that the labels on the green cables may have been switched, with the channel 1 cable labelled as channel 2, and the channel 2 cable labelled as channel 1. This will lead to a mismatch as to the left and right values displayed on the monitor and what the labels indicate on the cables. Should this potential problem occur during use, the values displayed on the monitor will be switched and will represent the opposite region being monitored. Therefore, there is a potential for incorrect diagnosis, leading to potential delay of appropriate treatment. To date, three complaints have been received about this problem worldwide, none of which resulted in adverse events. Instructions for Customers/Users Customers are to check devices in clinical use and in inventory: 1. Verify for the presence of the flag, sensor, and channel labels on the device. 2. Verify that the flag and sensor labels correspond to the correct channel label (A1 on left / B2 on right) on the housing. 3. If ei
Hazard
Classification Class II Reason for the Action Edwards Lifesciences has identified that during manufacturing, the laterality identification labels may be missing or inaccurately placed on the device. There is potential that the labels on the green cables may have been switched, with the channel 1 cable labelled as channel 2, and the channel 2 cable labelled as channel 1. This will lead to a mismatch as to the left and right values displayed on the monitor and what the labels indicate on the cables. Should this potential problem occur during use, the values displayed on the monitor will be switched and will represent the opposite region being monitored. Therefore, there is a potential for incorrect diagnosis, leading to potential delay of appropriate treatment. To date, three complaints have been received about this problem worldwide, none of which resulted in adverse events. Instructions for Customers/Users Customers are to check devices in clinical use and in inventory: 1. Verify for the presence of the flag, sensor, and channel labels on the device. 2. Verify that the flag and sensor labels correspond to the correct channel label (A1 on left / B2 on right) on the housing. 3. If ei
Official recall notice
ForeSight Oximeter Cable
Agency: Therapeutic Goods Administration
Official publication date: June 1, 2021
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