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SEAC Dental System - Model 2020 (2013-11-19)
- Starting date:
- November 19, 2013
- Posting date:
- January 6, 2014
- 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-37253
Recalled products
- SEAC Dental System - Model 2020
Reason
Field correction to the unit. Addition of a 100 PSI pressure relief valve and service warning label. Operational pressure in excess of 100 PSI can result in rupture of the air reservoir tank.
Affected products
A. SEAC Dental System - Model 2020
Lot or serial number
- 50341 to 592066
Model or catalog number
- 2020
Companies
- Manufacturer
-
ASI Medical, Inc.
130 - 13792 Compark Blvd.
Englewood
80112
Colorado
UNITED STATES