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Health product recall

CIOS ALPHA (2015-08-19)

Starting date:
August 19, 2015
Posting date:
September 1, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-54892

Affected Products

  1. CIOS ALPHA

Reason

It has been reported that under certain circumstances, when starting the system up or reconnecting the c-arm cable to the main unit, the error 5000/243 "no X-ray - FD re-initializes" may occur. The error refers to a potential hardware malfunction which requires a part replacement. When this error occurs, the system will become inoperable (i.e. no x-ray) until the affected part is replaced.

Affected products

A. CIOS ALPHA
 

Lot or serial number
  • 10071
  • 11137
  • 11138
Model or catalog number
  • 10308191
Companies
Manufacturer
Siemens Ag
Wittelsbacherplatz 2
Muenchen
80333
GERMANY