Recall Z-1673-2021 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Welch Allyn Inc
ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Model: 34XFHT-B Intended: ProBP 3400 automatically measures systolic and diastolic pressure (excluding neonates) and pulse rate, as well as calculates Mean Arterial Pressure (MAP).
| Date | Apr 22, 2021 |
| Status | Terminated |
| Reason | Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock |
| Root cause | Device Design |
| Action | 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 clean |
| Quantity | 119770 units |
| Distribution | Worldwide - US Nationwide distribution Foreign: Afghanistan Albania Algeria American Samoa Argentina Australia Austria Azerbaijan Bahamas (the) Bahrain Bangladesh Barbados Belgium Bermuda Bhutan Bolivia (Plurinational State of) Botswana Brazil Brunei Darussalam Bulgaria Cameroon Canada Chad Chile Ch |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101680 | WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES Welch Allyn, Inc., Jul 9, 2010 |