Home / Recalls / Draeger Medical Systems, Inc. / Z-2047-2018

Z-2047-2018 Class I Terminated

Recalled by Draeger Medical Systems, Inc. — Telford, PA

Recall Details

Product Type
Devices
Report Date
June 13, 2018
Initiation Date
May 15, 2018
Termination Date
February 8, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6711

Product Description

Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physician s office applications.

Reason for Recall

Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement

Distribution Pattern

Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY; and countries of: Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Benin, Bolivia, Bosnia-Herz., Botswana, Brazil, British Virgin Islands, Brunei Darussalam, Bulgaria, Burkina-Faso, Cambodia, Canada, Chile, Columbia, Congo, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, French Guiana, Macedonia, Georgia, Germany, Ghana, Greece, Greenland, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Kosovo, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Nicaragua, Nigeria, Norway, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, St Vincent, St Pier Miquel, Sweden, Switzerland, Tadzhikistan, Tanzania, Thailand, Trinidad Tobago, Tunisia, Turkey, Turkmenistan, United Kingdom, Uruguay, UAE, Venezuela, Vietnam, and Zimbabwe.

Code Information

All products

Other recalls by Draeger Medical Systems, Inc.

  • Z-1066-2025 Class II — Infinity Central Station. Model Number: MS26800 The Infinity CentralStation ( (January 14, 2025)
  • Z-2189-2024 Class II — Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, M (May 13, 2024)
  • Z-1992-2023 Class II — Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): R (May 16, 2023)
  • Z-1472-2023 Class II — Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse o (April 5, 2023)
  • Z-1471-2023 Class II — Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatri (April 5, 2023)
  • Z-1365-2022 Class II — Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. n (May 20, 2022)
  • Z-2046-2018 Class I — Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, c (May 15, 2018)
  • Z-1440-2014 Class I — Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part n (March 5, 2014)
  • Z-1298-2014 Class I — Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (E (February 7, 2014)
  • Z-0714-2014 Class II — Draeger Infinity Acute Care System Monitoring Solution (December 10, 2013)