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IsoAir Mattress
- Starting date:
- February 28, 2017
- Posting date:
- March 16, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-62660
Reason
Stryker is the distributor of the IsoAir system. The specification developer/manufacturer of the IsoAir system has determined that electrical interference emanating from the system may cause clinically unacceptable levels of signal artifact in electrophysiological monitoring devices, e.g. ECG, EKG or EEG. This only occurs when the active sensor technology (AST) cable from the air pump is connected to the surface. Stryker has received a few complaints associated with this issue.
Affected products
IsoAir Mattress
Lot or serial number
15C0036
Model or catalog number
2940-000-038
Companies
- Manufacturer
-
Stryker Medical
3800 E Centre Avenue
Portage
49002
UNITED STATES