Health product recall

"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