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Physiologic LuminA Blood Pressure Monitor

A.M.G. Médicale Inc · Model 106-934 · UDI-DI 00057565968887

DXN
10
510(k) clearances
7,287
Adverse events (16 deaths)
36
Recalls
427
Facilities

Description

This top of the line blood pressure monitor is completely automatic. Once the user is specified, all you have to do is to put on the BP cuff and press the start button. Its large and bright blue screen will insure no straining while reading your systolic, diastolic and pulse results. This blood pressure monitor will also automatically indicate where the user's results are on the 6 level, easy to understand, Hypertension Risk Chart. •Bright easy to read screen •Dual user, 60 memories each •Hypertension Risk Indicator (6 level color classification) •Heart rate indicator / pulse •Date and time indicator •Table top, fully Automatic BP monitor (arm type) •Large screen 2.7 in x 4 in (69 x 102 mm) •Backlight screen when reading is completed •Large, easy to see numbers: 30 mm (Systolic); 20 mm (Diastolic); 9 mm (Pulse) •Inflation/ Deflation icons •Average of Last 3 readings/ results •Irregular Heartbeat detection/ icon •Auto shut off: 3 minutes, if left untouched or forgotten •Low battery indicator insures that users are never without their information/ unable able to take their reading •Carrying bag Meets all required Canadian & US FDA Standards including ANSI/AAMI SP-10 & ESH International Protocol Includes: Blood pressure monitor, medium size arm cuff, fits 8.7” to 14.2” (22 to 36 cm) arm circumference, transport bag and instructions. Requires 4 AA batteries (not included) A Large cuff is available (#106-931) (optional) Power adaptor: DC 6V 1000mA AC (#106-933) (not included - optional)

Recalls

DateFirmReason
2025-02-24PYRAMES INCSingle-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. C
2024-08-30MEDLINE INDUSTRIES, LP - NorthfieldIt has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as
2024-08-30MEDLINE INDUSTRIES, LP - NorthfieldIt has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as
2024-08-30MEDLINE INDUSTRIES, LP - NorthfieldIt has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as
2024-03-26Baxter Healthcare CorporationBaxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical s
2024-03-26Baxter Healthcare CorporationBaxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical s
2024-03-26Baxter Healthcare CorporationBaxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical s
2024-02-26MEDLINE INDUSTRIES, LP - NorthfieldThe firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the firms Receiving Dept. a
2021-05-17Mediana Co., Ltd.In some cases the equipment fails to power up and/or key or button unresponsive or not working.
2021-04-22Welch Allyn IncPotential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.