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NCMDR Recall
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Reference Number:
mdprc 077 05 12 000
Date submitted:
5/28/2012
Manufacturer:
Philips Medical Systems
Device Type:
All DigitalDiagnost (with release 2.0.2 and 2.0.2SP1
Description:
Image, PACS system
Medical Device Identifier:
12NC: 989001083902 Software ReI. 2.0.2 (4512201 06094) Software ReI. 2.0.2SP1 (451220106095) Software ReI. 2.0.2SP1 with OS SP4 (4512 201 06096)
Reason of Field Safety Corrective Action:
With DigitalDiagnost (DiDi) R 2.0.2 a mirrored "R in a circle" is burnt into the DESCRIPTION image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a circle" appears in the lower left corner. This can be mistaken for a "right patient side" marker, although this can appear on the left patient side.
Remedy Action:
Philips plans to supply a software update solving the described mirror icon problem. A Philips Service Engineer will contact you as soon as the Field Action Kit is ready to be implemented.
Athorized Representative/Importer/Distributor:
Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:
NCMDR
Source Ref. Number:
0CE3D936A22A0
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
Philips Medical Systems.pdf
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