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DIGITAL FLUOROGRAPHY SYSTEM, ULTIMAX-I & REMOTE CONTROL R/F SYSTEM ZEXIRA (2015-10-30)
- Starting date:
- October 30, 2015
- 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-55862
Affected Products
- DIGITAL FLUOROGRAPHY SYSTEM
- ULTIMAX-I
- REMOTE CONTRL R/F SYSTEM ZEXIRA - MAIN UNIT
Reason
By the inappropriate processing of the software for the image-processing device(HDR-08A), one-shot images are saved as black images in the hard disk, and they are displayed as black images on the system monitor, even though these images are displayed normally on the live monitor.
Affected products
A. DIGITAL FLUOROGRAPHY SYSTEM
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
HDR-08A
Companies
- Manufacturer
-
Toshiba Medical Systems Corporation
1385 Shimoishigami
OTAWARA-SHI
324-8550
JAPAN
B. ULTIMAX-I
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
DREX-U180_/K1
DREX-UI80_/K2
Companies
- Manufacturer
-
Toshiba Medical Systems Corporation
1385 Shimoishigami
OTAWARA-SHI
324-8550
JAPAN
C. REMOTE CONTRL R/F SYSTEM ZEXIRA - MAIN UNIT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
DREX-ZX80_/K4
Companies
- Manufacturer
-
Toshiba Medical Systems Corporation
1385 Shimoishigami
OTAWARA-SHI
324-8550
JAPAN