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Medical Devices Sector
قطاع الأجهزة الطبية
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NCMDR Recall
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Reference Number:
mdprc 051 05 13 000
Date submitted:
5/15/2013
Manufacturer:
Stryker Communications
Device Type:
Router and Control System , Switchpoint Infinity 3 (SPI3)
Description:
Switchpoint Infinity 3 (SPI3) Router and Control System (Figure.1) is intended to be a central point of control and integration of ancillary compatible equipment, audio, video, and data routing, as well as teleconferencing for medical personnel
Medical Device Identifier:
(Name : ASSY, SPI3, SOl - VIDEO RX . Part No : 0100224713 ) ( Name : PKG, SWITCHPOINT INFINITY 3 . Part No : 0678001000 ) ( Name : REPAIR KIT, SPI3, SOl AND VIDEO RECEIVE (PIN) . Part No : 0678001052) ( Name : UPGRADE KIT, SPI3, VIDEO RX . Part No : 0678001127 )
Reason of Field Safety Corrective Action:
Sources utilizing S-video and Composite inputs, Phase Alternating Line (PAL) signals appear with jagged edges on all diagonal lines resulting in poor video quality
Remedy Action:
Immediately check your internal inventory and locate all subject devices pending upgrade of these devices by a Stryker Representative. The manufacturer has confirmed that devices may continue to be used pending inspection/upgrade
Athorized Representative/Importer/Distributor:
Al-Faisaliah Medical System, Riyadh, (011 ) 2119948
Report Source:
NCMDR
Source Ref. Number:
4E22E540D826D
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
Stryker.pdf
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