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Roho Single Comparment Cushion with Sensor Ready Technology (2017-03-17)
- Starting date:
- March 17, 2017
- Posting date:
- April 4, 2017
- 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-62912
Affected Products
A. Roho High Profile Single Compartment Cushion With Sensor Ready Technology
B. Roho Mid Profile Single Compartment Cushion With Sensor Ready Technology
Reason
A problem was discovered internally with a supplied component for the affected products. When a smart check by ROHO is used to perform a smart setup with one of the affected cushions, the nonconforming part may adversely affect the setup process resulting in an improper cushion setup.
Affected products
A. Roho High Profile Single Compartment Cushion with Sensor Ready Technology
Lot or serial number
Serial numbers A2920163 through A3185287
Model or catalog number
More than 10 numbers, contact manufacturer
Companies
- Manufacturer
-
ROHO, Inc.
100 N. Florida
Belleville
5429
Illinois
UNITED STATES
B. Roho Mid Profile Single Compartment Cushion with Sensor Ready Technology
Lot or serial number
Serial numbers A2920163 through A3185287
Model or catalog number
More than 10 numbers, contact manufacturer
Companies
- Manufacturer
-
ROHO, Inc.
100 N. Florida
Belleville
5429
Illinois
UNITED STATES