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PNEUMO SURE HIGH FLOW INSUFFLATOR - MAIN UNIT (2016-03-28)
- Starting date:
- March 28, 2016
- Posting date:
- April 22, 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-58028
Affected products
A. PNEUMO SURE HIGH FLOW INSUFFLATOR - MAIN UNIT
Reason
When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and the red "check gas supply" symbol would appear on the display, immediately suspending insufflation.
Affected products
A. PNEUMO SURE HIGH FLOW INSUFFLATOR - MAIN UNIT
Lot or serial number
1101CE178
Model or catalog number
620-040-610
Companies
- Manufacturer
-
Stryker Endoscopy
5900 Optical Court
San Jose
California
UNITED STATES