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المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall
| Reference Number: |
mdprc 049 11 15 000 |
| Date submitted: |
11/10/2015 |
| Manufacturer: | Philips Healthcare |
| Device Type: | All Allura Xper, AlluraClarity, Allura CV, Allura Centron and UNIQ systems |
| Description: | X-ray systems |
| Medical Device Identifier: | Productcode: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722034, 722035, 722038, 722039, 722058 and 722400. |
| Reason of Field Safety Corrective Action: | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. |
| Remedy Action: | -Philips will inform customers via this Field Safety Notice (FSN) about the presence of the live and still image indications on the system as mentioned in the Instructions for Use. (IFU)
-Philips will strongly advise customers via this Field Safety Notice (FSN) to ensure the audible signal (X-ray buzzer) is always enabled.
-Philips will remind customers via this Field Safety Notice (FSN) to activate only ONE fluoroscopy pedal at time.
-Philips will strongly advise customers via this Field Safety Notice (FSN) to configure the footswitch to the default Philips configuration.
-The system is working fully within specification and accordance with its intended use.
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| Athorized Representative/Importer/Distributor: | Philips Healthcare Saudi Arabia Ltd. |
| Report Source: | NCMDR |
| Source Ref. Number: | 69B65C5E051DE |
| SFDA Comments: | SFDA urges all hospitals that have devices subjected to recall, to contact the company. |
| Attachments: |  Philips Healthcare-2.pdf |
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