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OHMEDA Infant Warmer System
- Starting date:
- August 25, 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-60086
Affected Products
- OHMEDA Infant Warmer System
- Infant Warmer System
Reason
Hot screws from the "heater head" of the IWS could fall onto the bed if the "heater head" assembly has been improperly serviced. The attached service manual addendum provides instructions for checking and tightening the screws. During each annual preventive maintenance check, continue to ensure that the screws are tight.
Affected products
A. OHMEDA Infant Warmer System
Lot or serial number
More than 10 lots, contact manufacturer.
Model or catalog number
- 3000
- 3050
- 3100
- 3150
- 3300
- 3400
- 3500
- 4000
- 4300
- 4400
Companies
- Manufacturer
-
Ohmeda Medical, A Division of Datex Ohmeda Inc.
8880 GORMAN ROAD
LAUREL
Maryland
UNITED STATES
B. Infant Warmer System
Lot or serial number
More than 10 lots, contact manufacturer.
Companies
- Manufacturer
-
Ohmeda Medical, A Division of Datex Ohmeda Inc.
8880 GORMAN ROAD
LAUREL
Maryland
UNITED STATES