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 Physici

The firm, Drager, sent an "Urgent Medical Device Safety Notices" were distributed to customers on 5/15/18. The letter described the product, problem and actions to be taken. The letters instruct customers to perform the following: Enclosed with this letter are label/s and instructions on how and hwere to apply the label onto your device/s. Please make sure that all JM-105/JM-103 devices in your hospital are labeled according to the instructions in a timely manner. Please make sure that in your clinical environment the users are trained in the use of the equipment and the clinical workflow is set up in a way that the device is not used as a diagnostic device. In case of any uncertainty (e.g. risk factors cannot be evaluated), a blood test needs to be performed. The risk factors according to the Guideline of American Academy of Pediatrics are summarized in the attached Sample Usage Protocol Template as well as the recommended method to use the device as intended in a clinical environment. Please completed and return the attached Customer Reply card. If you have any questions regarding, please call 1-800-437-2437(press 1 at the prompt than 32349) between the hours of 8:00am-4:30pm EST.