FDAApril 22, 2021device
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).
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock
What to do
FDA enforcement status: Terminated
Brands named
welch allynwelch
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280...2021-09-03
- FDABraun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment. Model: 60002021-07-20
- FDAGS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall Transformer is intended for use in ambulatory and acute care settings.2021-04-22
- FDAAM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.2021-03-31
- FDAELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.2021-03-31
- FDASurveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.2021-03-31
- FDAELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.2021-03-31
- FDAELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead.2020-11-11
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