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IMAGE SUITE 3.0/4.0 SOFTWARE (2016-04-20)
- Starting date:
- April 20, 2016
- Posting date:
- May 16, 2016
- 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-58354
Affected products
- IMAGE SUITE 4.0 WITH MINI-PACS AND DICOM STORE
- IMAGE SUITE 3.0 WITH MINI-PACS OPTIONS AND HOT FIX 3004 SOFTWARE PATCH
- IMAGE SUITE 3.0 WITH MINI-PACS OPTIONS AND HOT FIX 3004 SOFTWARE
Reason
Carestream has identified a software issue that if the image suite software receives Computed Tomography (CT) and Magnetic Resonance (MR) images with the image orientation (patient) tag specified, and the overlay is configured to display this tag, the L (left) and R (right) and A (anterior) and P (posterior) overlay text could be displayed reversed.
Affected products
-
IMAGE SUITE 4.0 WITH MINI-PACS AND DICOM STORE
Lot or serial number
- 85013463
Model or catalog number
- 1056191
Companies
- Manufacturer
-
Carestream Health
150 Verona Street
Rochester
14608
New York
UNITED STATES
B. IMAGE SUITE 3.0 WITH MINI-PACS OPTIONS AND HOT FIX 3004 SOFTWARE PATCH
Lot or serial number
52412542
54842775
Model or catalog number
1036490
Companies
- Manufacturer
-
Carestream Health
150 Verona Street
Rochester
14608
New York
UNITED STATES
C. IMAGE SUITE 3.0 WITH MINI-PACS OPTIONS AND HOT FIX 3004 SOFTWARE
Lot or serial number
52412542
54842775
Model or catalog number
1036508
Companies
- Manufacturer
-
Carestream Health
150 Verona Street
Rochester
14608
New York
UNITED STATES