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Health product recall

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