"Ysio Max, Luminos DRF Max, Uroskop Omnia Max & Multitom Rax (2020-04-28) "
- Starting date:
- April 28, 2020
- Posting date:
- June 5, 2020
- 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-73233
Last updated: 2020-06-05
Affected Products
A. Ysio Max
B. Luminos DRF Max
C. Uroskop Omnia Max
D. Multitom Rax
Reason
Siemens is notifying users about a software update VF10F. Systems with current version VF10E_HF02 will be upgraded to VF10F to eliminate various bugs. The major bugs that are being corrected with this software patch are as follows:
- WLAN access point issues
- Movement issues
- Time delay between acquisitions
- Image acquisition
- Not started radiation within the detector window
- Image Recovery
- Inlet/Outlet View Pelvis
- Requirements of certain chapter of regulation DIN 6862.2
- 64Bit Service Key
- No error message with activated DMG Micro switch will be displayed
- Security
- Cropping
- Fluoro Time unit indicator missing on the exported DICOM Dose SC
- The update is not providing new features or new functionalities.
Affected products
A. Ysio Max
Lot or serial number
VF10E_HF02
Model or catalog number
10762470
Companies
- Manufacturer
-
Siemens Healthcare GMBH
Henkestr. 127
Erlangen
91052
GERMANY
B. Luminos DRF Max
Lot or serial number
VF10E_HF02
Model or catalog number
10762471
Companies
- Manufacturer
-
Siemens Healthcare GMBH
Henkestr. 127
Erlangen
91052
GERMANY
C. Uroskop Omnia Max
Lot or serial number
VF10E_HF02
Model or catalog number
10762473
Companies
- Manufacturer
-
Siemens Healthcare GMBH
Henkestr. 127
Erlangen
91052
GERMANY
D. Multitom Rax
Lot or serial number
VF10E_HF02
Model or catalog number
10860700
Companies
- Manufacturer
-
Siemens Healthcare GMBH
Henkestr. 127
Erlangen
91052
GERMANY