The Recall Desk

FDA (Devices) recall action 83979

Mindray DS USA, Inc. dba Mindray North America recalled 4 products on 2019-11-06

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2019-11-06
Critical
0
Units
143

Why these products were recalled

NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature 2. NIBP hose blockage identification function

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • ModerateFDA (Devices)··2019-11-06

    Mindray Accutorr 7 Vital Signs Monitor Software Recall

    Mindray is recalling 107 Accutorr 7 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.

    Product
    Accutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP
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    0 states
  • ModerateFDA (Devices)··2019-11-06

    Mindray Rosebud Vital Signs Monitor Recalled for Unapproved Software Features

    Mindray is recalling 9 Rosebud Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.

    Product
    Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressur
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    0 states
  • ModerateFDA (Devices)··2019-11-06

    Mindray Rosie4 Vital Signs Monitor Recalled for Software Clearance Issues

    Mindray is recalling 14 Rosie4 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.

    Product
    Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP). Te
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    0 states
  • ModerateFDA (Devices)··2019-11-06

    Mindray Accutorr 3 Vital Signs Monitor Recalled for Software Features

    Mindray is recalling 13 Accutorr 3 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.

    Product
    Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pres
    Category
    Distribution
    0 states