Health product recall

Ysio Max, Luminos dRF Max, Uroskop Omnia Max (2019-05-08)

Starting date:
May 8, 2019
Posting date:
May 31, 2019
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-70057

Last updated: 2019-05-31

Affected Products

  1. Ysio Max
  2. Luminos dRF Max
  3. Uroskop Omnia Max

Reason

Siemens is releasing SW version VF10E that resolves the following issues and prevents them from recurring.

  • Image quality issues with rad image caused by incorrect processing in certain workflows following fluoro
  • Sporadic issue with ortho image series caused by errors in individual image frames
  • The primary cause for the 'watchdog' error during system startup

The update is not providing new features or new functionality.

Affected products

A. Ysio Max

Lot or serial number
  • 27272
  • 27293
  • 27377
  • 27412
Model or catalog number

10762470

Companies
Manufacturer
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY

B. Luminos dRF Max

Lot or serial number
  • 7226
  • 7275
  • 7306
  • 7327
Model or catalog number

10762471

Companies
Manufacturer
Siemens Healthcare GmbH
Henkestr. 127
Erlangen
91052
GERMANY

C. Uroskop Omnia Max

Lot or serial number

5083

Model or catalog number

10762473