Recall Z-1673-2021

Reason for recall

Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock

FDA-determined cause: Device Design

Action taken

Welch Allyn, Inc. (a Hill-Rom Company) issued Customer Medical Device Correction letter ( FSCA-identifier: MOD1329) mailed (with signature service) on April 22, 2021(with signature service) via third Party. The letter states reason for recall, health risk and risk mitigations until the updated Instructions for Use (IFU) becomes available. To minimize risk of potential electrical shock be sure to follow these cleaning recommendations: When Cleaning is performed: 1. Unplug the power supply from the outlet. 2. Ensure the cleaning cloth is not soaking (not dripping or over saturated) with cleaning fluid. 3. Apply minimal pressure on wipe when cleaning; avoid wiping gap areas identified on adapter plug as these areas are most susceptible to liquid ingress. 4. Ensure the power supply and power cord are dry before plugging into electrical outlet. 5. Hold the sides of the power supply when plugging into electrical outlet as pictured below. Avoid contact with bottom of the power supply where cleaning fluid is mostly likely to have accumulated The customer will be instructed to sign acknowledgement form to confirm receipt and return to a dedicated email address. Distributors will be asked to forward to their end users. They can request an electronic copy of the FSN and response form to share with end users until updated IFU becomes available. Distributors will be provided instruction on communication with their end users once response form is received. Consignees of new sales will receive the Field Safety Notice until the IFU is updated. This will be done by pulling updated consignee lists monthly and providing any new consignees with the customer letter. .