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Pental Digital Video Capture (2017-05-30)
- Starting date:
- May 30, 2017
- Posting date:
- June 21, 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-63666
Affected Products
A. Digital Video Capture Module
B. HD-Digital Video Capture
Reason
Pentax Medical has become aware that some customers may not have been provided with an isolation transformer when they purchased a Pentax medical computer system mounted to a cart. The electrical safety requirements for these systems requires the use of an isolation transformer to protect patients from electrical shock.
Affected products
A. Digital Video Capture Module
Lot or serial number
33413-10/81J01621NA
41861-16/CDC15A47600
Model or catalog number
MODEL 9200C
Companies
- Manufacturer
-
Pentax of America, Inc.
3 Paragon Drive
Montvale
07645
New Jersey
UNITED STATES
B. HD-Digital Video Capture
Lot or serial number
4015609/B4LMQS001473
Model or catalog number
MODEL 9310HD
Companies
- Manufacturer
-
Pentax of America, Inc.
3 Paragon Drive
Montvale
07645
New Jersey
UNITED STATES