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Infant Warmer system (2016-08-09)
- Starting date:
- August 9, 2016
- Posting date:
- August 19, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-59898
Affected products
- Infant Warmer system
- Infant Warmer System (IWS)
Reason
Hot screws from the heater head of the infant warmer system could fall onto the bed if the "heater head" assembly has been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient could result. Two injuries have been reported as a result of this issue.
Affected products
-
Infant Warmer system
Lot or serial number
Not Applicable
Model or catalog number
3051
Companies
- Manufacturer
- Ohmeda Medical, A Division Of Datex Ohmeda Inc.
B. Infant Warmer System (IWS)
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
2001
3000
3050
3100
3300
3400
3500
4000
4300
4400
5000
Companies
- Manufacturer
- Ohmeda Medical, A Division Of Datex Ohmeda Inc.