Events

Recall of Device Recall Pulsox

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Minolta Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    27692
  • Event Risk Class
    Class 2
  • Event Number
    Z-0289-04
  • Event Initiated Date
    2003-11-14
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30365
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Oximeter - Product Code DQA
  • 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.

Device

Device Recall Pulsox
  • Model / Serial
    Model 3Si, Serial Nos: 22001453-22001469; 22001471-22001512; 22001514-22001599; 22001600-22001626; 22001628-22001632; 22001635-22001643; 22001645-22001651; 22001653-22001659; 22001661-22001676; 22001678-22001683; 22001685-22001686; 22001688-22001691; 22001712-22001714; 22001717-22001719; 22001721-22001723; 22001725; 22001727-22001732; 22001734-22001737; 22001740-22001745; 22001747-22001765; 22001767-22001770; 22001772; 22001776; 22001860; 22001862; 22001865; 22001868; 22001879; 22001881; 22001882; 22001885; 22001887; 22001893; 22001897; 22001899; 22001905.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The units were shipped to one distributor in Utah.
  • Product 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.
  • Manufacturer
    Minolta Corp

Manufacturer

Minolta Corp
  • Manufacturer Address
    Minolta Corp, 101 Williams Dr, Ramsey NJ 07446-1217
  • Source
    USFDA