Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor ...
FDA Device Recall #Z-2046-2018 — Class I — May 15, 2018
Recall Summary
| Recall Number | Z-2046-2018 |
| Classification | Class I — Serious risk |
| Date Initiated | May 15, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Draeger Medical Systems, Inc. |
| Location | Telford, PA |
| Product Type | Devices |
| Quantity | 10363 |
Product Description
Draeger Jaundice Meter JM-103 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" ---" 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.
Lot / Code Information
All products
Other Recalls from Draeger Medical Systems, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1066-2025 | Class II | Infinity Central Station. Model Number: MS26800... | Jan 14, 2025 |
| Z-2189-2024 | Class II | Infinity Acute Care System (IACS) Monitoring Sy... | May 13, 2024 |
| Z-1992-2023 | Class II | Draeger Softbed Resuscitaire and/or Birthing Ro... | May 16, 2023 |
| Z-1472-2023 | Class II | Draeger Infinity M300 and M300+, for use with t... | Apr 5, 2023 |
| Z-1471-2023 | Class II | Draeger Infinity CentralStation (ICS), centrali... | Apr 5, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.