Draeger Jaundice Meter JM-105 Recalled for Misinterpreted Display Readings
Draeger Medical Systems is recalling 6,711 Draeger Jaundice Meter JM-105 devices 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 is defined as a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. The hazard is a user misinterpretation of a display symbol rather than a direct physical defect causing injury.
Plain-English summary
Draeger Medical Systems, Inc. is recalling 6,711 units of the Draeger Jaundice Meter JM-105. 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 for home use or as a standalone diagnostic tool for hyperbilirubinemia.
The recall was initiated because users have misinterpreted the display for out-of-range measurements, indicated by a blinking "-0-", to mean a zero measurement. This misinterpretation could lead to incorrect clinical assessments.
The affected devices were distributed worldwide, including nationwide in the United States and in numerous countries across multiple continents. Consumers and healthcare facilities should stop using the affected devices and contact Draeger Medical Systems for further instructions.
The recalled product
- Product
- 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 hyperbilirubine
- Manufacturer
- Draeger Medical Systems, Inc.
- Hazard
- Affected units
- 6,711
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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