| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01200-1 |
| Product Name/Description |
TCM CombiM module (used with Radiometer Transcutaneous Monitors)
Product Code: 903-111
Affected Serial Numbers: below 903-111R0174Nxxx
ARTG Number:167226 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
RADIOMETER has recently become aware that TCM Combi M modules with a serial number below 903-111R0174Nxxx* may, on rare occasions, have an error that will cause the alarm sound to be higher than the pre-set maximum volume.
If the alarm sound is higher than the pre-set volume then critically ill premature infants may experience a critical stress reaction if the TCM Combi M monitor is placed close to the infant and the too high alarm is not silenced.
|
| Recall Action |
Recall |
| Recall Action Instructions |
Radiometer is advising users with devices in Newborn or NICU units to turn off the monitor and contact Radiometer if the error occurs. Radiometer will be replacing all units which are used in these areas. Radiometer is providing a warning label to be placed on all TCM4 units which are not used in the Newborn or NICU units, and to advise Radiometer if the error occurs. This action has been closed-out on 31/08/2016. |
| Contact Information |
1800 247 254 |