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Medical Devices Sector
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MHRA Recall
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Reference Number:
mdprc 061 01 13 000
Date submitted:
1/19/2013
Manufacturer:
Siemens Medical Solutions
Device Type:
X-ray, fluoroscopy systems, Iconos R200 C20 or Iconos R200 T20
Description:
X-ray, fluoroscopy systems
Medical Device Identifier:
Iconos R200 C20 or Iconos R200 T20
Reason of Field Safety Corrective Action:
A potential malfunction and resulting hazard to patient and staff with the Iconos R200 C20 or Iconos R200 T20. This malfunction is possible in cases where the table vertical tilt movement is obstructed by a solid object (e.g. footstool) resulting in a collision. This can result in damage to the system mechanics that may not necessarily prevent the table from functioning immediately, but can lead to complete failure of the table mounting mechanics. In this case the table may drop, resulting in potentially hazardous situations for patients and/or staff.
Remedy Action:
A Siemens service representative will investigate if parts need to be exchanged to restore the system safety and function, in this time follow instructions from them (see attached).
Athorized Representative/Importer/Distributor:
Siemens Medical Solutions, Riyadh, (01) 277-8111
Report Source:
MHRA
Source Ref. Number:
2013/001/007/601/042
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
Siemens Medical Solutions.pdf
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Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.