Draeger Jaundice Meter JM-103 Recalled for Measurement Display Misinterpretation
Draeger Medical Systems is recalling the Jaundice Meter JM-103 because users may misinterpret the out-of-range display as a zero measurement.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class I, which by definition is unlikely to cause adverse health consequences. The hazard involves user misinterpretation of a display rather than a direct physical defect causing injury.
Plain-English summary
Draeger Medical Systems, Inc. is recalling the Draeger Jaundice Meter JM-103. The device is intended for use in hospitals, clinics, or doctor's offices under a physician's supervision to assist clinicians in monitoring newborn infants. It is not intended as a standalone diagnostic tool for hyperbilirubinemia and is not for home use.
The recall is being conducted because users have misinterpreted the display for out-of-range measurements, indicated by a blinking "---", to mean a zero measurement. This misinterpretation could lead to incorrect clinical assessments.
The recall affects 10,363 units distributed worldwide, including the United States and numerous international countries. Consumers and healthcare facilities should stop using the device and contact Draeger Medical Systems for further instructions.
The recalled product
- Product
- 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 hyperbilirubin
- Manufacturer
- Draeger Medical Systems, Inc.
- Hazard
- Affected units
- 10,363
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All products
Distribution
Part of a larger recall action
This product is one of 2 recalled by Draeger Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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