Health product recall

MOBILETT Elara Max (2020-04-23)

Starting date:
April 23, 2020
Posting date:
May 15, 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-73091

Last updated: 2020-05-15

Affected Products

MOBILETT Elara Max

Reason

Siemens is notifying users of MOBILETT Elara Max 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

MOBILETT Elara Max

Lot or serial number
  • 10043
  • 10059
  • 10058
  • 10670
  • 10764
Model or catalog number
  • 11107444
Companies
Manufacturer
Siemens Healthcare GMBH
Henkestr. 127
Erlangen
91052
GERMANY