COOK Vacuum Pump and Aspiration Unit (2018-03-01)
- Starting date:
- March 1, 2018
- Posting date:
- March 23, 2018
- 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-66278
Affected products
A. VACUUM PUMP
B. COOK ASPIRATION UNIT
Reason
The internal mains wiring does not fully comply with the requirements of the medical electrical equipment standard IEC60601-1 Edition 3.0. IEC60601-1 states that conductors and connectors of medical electrical equipment shall be secured or insulated so that accidental detachment shall not result in a hazardous situation. The K-MAR-5200 mains wiring is secured, but the mechanism is not considered suitable under the current version of IEC60601-1.
Affected products
A. VACUUM PUMP
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
K-MAR-5200
Companies
- Manufacturer
-
William A. Cook Australia, Pty. Ltd.
95 Brandl Street
Eight Mile Plains, Queensland
4113
AUSTRALIA
B. COOK ASPIRATION UNIT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
K-MAR-5200-US
Companies
- Manufacturer
-
William A. Cook Australia, Pty. Ltd.
95 Brandl Street
Eight Mile Plains, Queensland
4113
AUSTRALIA