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Axiom Luminos DRF System-Main Unit (2014-04-22)
- Starting date:
- April 22, 2014
- Posting date:
- May 5, 2014
- 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-39323
Recalled Products
Axiom Luminos DRF System-Main Unit
Reason
Under rare environmental conditions (i.e., extremely dry air in combination with a highly isolated floor) electrostatic discharges (ESD) greater than 8 kV at the system control console may trigger an unintended movement of the system which may cause an emergency situation, danger to the patient (e.g., falling off the table, squeezing), to operating personnel or to the unit.
Affected products
Axiom Luminos DRF System-Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
10094200
Companies
- Manufacturer
-
Siemens AG
Wittelsbacherplatz 2
Muenchen
80333
GERMANY