BEUDAMED
    FDA Recall Terminated

    Pulsox-3Si. LCD, SpO2, PR, Pulse strength bar, Motion artifact, Low battery message, Error message, Event mark, Measuring range Sp02 (%) 0 to 100, Pulse rate 20 to 250, Measuring accuracy +/- 2% (70 to 100), Pulse rate +/- 2%, Sp02 alarm, no, Probe type, finger, multi-site, Patient range adult to neonatal, memory function Approx. 24 hrs, printer/recorder optional accessory, output RS232 w/optional interface module, power supply 2 AAA batteries, Battery life approx. 48 hours, size: 42x68x20mm, weight 42g.

    Recall: Z-0289-04 · Initiated November 14, 2003

    Recall

    Recall Number
    Z-0289-04
    Event Number
    27692
    Firm
    Minolta Corp
    FEI Number
    1000136179
    Product Code
    DQA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 14, 2003
    Posted
    July 20, 2004
    Terminated
    April 14, 2004
    Address
    101 Williams Dr, Ramsey, NJ, 07446-1217

    Description

    Pulsox-3Si. LCD, SpO2, PR, Pulse strength bar, Motion artifact, Low battery message, Error message, Event mark, Measuring range Sp02 (%) 0 to 100, Pulse rate 20 to 250, Measuring accuracy +/- 2% (70 to 100), Pulse rate +/- 2%, Sp02 alarm, no, Probe type, finger, multi-site, Patient range adult to neonatal, memory function Approx. 24 hrs, printer/recorder optional accessory, output RS232 w/optional interface module, power supply 2 AAA batteries, Battery life approx. 48 hours, size: 42x68x20mm, weight 42g.

    Reason

    Error in the internal software. When a pulse level is high or subject has SPO2 of less than 80%, the data shifts.

    Action

    Distributor provided customer list to Konica Minolta who initiated phone calls to the customers on 11/14/2003.

    Distribution

    The units were shipped to one distributor in Utah.

    Quantity

    291