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No Gas Regulator, Cga 626
- Starting date:
- July 11, 2017
- Posting date:
- August 14, 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-64132
Reason
Manufacturer has received reports of gas regulators being incorrectly set causing the device to initiate a 'no pressure too high' alarm. This problem was evaluated by the regulator manufacturer and the root cause was a production issue. Potential incorrect setting of a regulator resulting in a 'no pressure too high' alarm is not regarded a patient risk.
Affected products
No Gas Regulator, Cga 626
Lot or serial number
More than 100 numbers, contact manufacturer
Model or catalog number
68 81 836
Companies
- Manufacturer
-
Maquet Critical Care AB
Rontgenvagen 2
Solna