Dräger Jaundice Meter JM-103 and JM-105 (2018-05-09)
- Starting date:
- May 9, 2018
- Posting date:
- May 18, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66804
Affected products
A. DRAGER JAUNDICE METER JM-103
B. DRAGER JAUNDICE METER JM-105
Reason
Draeger's continuous post market surveillance has shown that some users have concerns about the method used by JM-103 & JM-105 to indicate that a taken measurement is out of range (higher than the measuring range of the device). As described in the instructions for use and in the device's training materials, the JM-103 displays a blinking '- - -' and the JM-105 displays a blinking '- o -' when the measurement is out of range. The measuring range is defined to 340 mol/l / 20 mg/dl.
Affected products
A. DRAGER JAUNDICE METER JM-103
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
MU20606
Companies
- Manufacturer
-
Draeger Medical Systems, Inc.
3135 Quarry Road
Telford
18969
UNITED STATES
B. DRAGER JAUNDICE METER JM-105
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
MU20105
Companies
- Manufacturer
-
Draeger Medical Systems, Inc.
3135 Quarry Road
Telford
18969
UNITED STATES