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Linear X-Ray Collimator and Progeny Vantage Panoramic X-Ray System (2014-11-19)
- Starting date:
- November 19, 2014
- Posting date:
- April 27, 2015
- 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-53023
Recalled Products
A. Linear MC150 Collimator
B. Linear II Collimator
C. Progeny Vantage Panoramic X-ray System with Cephalometric Extensions with Sensor
D. Progeny Vantage Panoramic X-ray System Cephalometric Extensions with Sensor
Reason
Device label failed to pass the JEC 60601-1 durability test and the affected device label may lose legibility during the useful life of the device.
Affected products
A. Linear MC150 Collimator
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
70-63XXX
Companies
- Manufacturer
-
Midmark Corporation
675 Heathrow Drive
Lincolnshire
60069
Illinois
UNITED STATES
B. Linear II Collimator
Lot or serial number
FA26112
Model or catalog number
70-43XXX
Companies
- Manufacturer
-
Midmark Corporation
675 Heathrow Drive
Lincolnshire
60069
Illinois
UNITED STATES
C. Progeny Vantage Panoramic X-ray System with Cephalometric Extensions with Sensor
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
V5000
Companies
- Manufacturer
-
Midmark Corporation
675 Heathrow Drive
Lincolnshire
60069
Illinois
UNITED STATES
D. Progeny Vantage Panoramic X-ray System Cephalometric Extensions with Sensor
Lot or serial number
1Z08011
1Z08012
IZ08013
Model or catalog number
C6000
Companies
- Manufacturer
-
Midmark Corporation
675 Heathrow Drive
Lincolnshire
60069
Illinois
UNITED STATES