Device Recall Propaq LT 802LT series Vital Signs Monitor

  • Model / Serial
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to United Arab Emirates, Argentina, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Columbia, Costa Rica, Czech Republic, Germany, Denmark, Ecuador, Spain, France, United Kingdom, Greece, Hong Kong,Taiwan, Ireland, Italy, Japan, Korea, Republic of, Kuwait, Lithuania, Luxemborg, Mexico, Malaysia, Mozambique, Namibia, Netherlands, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Sierra Leone, El Salvador, Thailand, Turkey, Uganda, Vietnam, Kosovo, and South Africa.
  • Product Description
    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. || These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. || intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Welch Allyn Protocol, Inc, 8500 Sw Creekside Pl, Beaverton OR 97008
  • Manufacturer Parent Company (2017)
  • Source
    USFDA