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المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall
| Reference Number: |
mdprc 094 12 18 000 |
| Date submitted: |
12/20/2018 |
| Manufacturer: | Philips Healthcare |
| Device Type: | Intera, Omniva, Enterprise, Achieva, Achieva XR, Achieva Conversion, Panorama HFO, Ingenia, SmartPath to dStream, Multiva, Prodiva, MR OR, MR-RT, MR-Linac, MR-Marlin systems |
| Description: | MRI systems |
| Medical Device Identifier: | Intera, Omniva, Enterprise, Achieva, Achieva XR, Achieva Conversion, Panorama HFO, Ingenia, SmartPath to dStream, Multiva, Prodiva, MR OR, MR-RT, MR-Linac, MR-Marlin systems |
| Reason of Field Safety Corrective Action: | Philips MR systems are standard equipped with two ceiling speakers, positioned in the front and/or rear of the MR system. These speakers enable communication between the operator in the examination room and the patient and offer stereo music or ambient experience audio.
These speakers are in most cases fixated in the suspended ceiling of the MR examination room according the Philips service instructions. The Philips Planning Reference Data (PRD) prescribes the suspended ceiling must be strong enough to hold 25 N speakers.
However in very rare cases, due to external influences (hospital facility maintenance, water leakage, degradation of speaker fixation) during the lifetime of the MR system, the ceiling speaker(s) could fall from their position and be pulled to the MR system by the magnetic field.
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| Remedy Action: | ACTION TO BE TAKEN BY CUSTOMER I USER:
Following checks/actions by the customer are recommended:
- Check if the speakers are mounted in the ceiling.
- Visually check for signs of fixation degradation: e.g. water leakage, color changes of ceiling tiles, poorly positioned tiles.
- In case of suspected insufficient fixation, do not correct the
fixation yourself, but immediately contact your local
Service/Philips representative.
ACTIONS PLANNED BY PHILIPS:
Via FC078100484 an additional fixation will be installed. This nonmagnetic’ mechanical safety connection will be fixated to the ceiling speaker(s) and anchored to an external fixation point e.g. the ceiling roof, suspended ceiling rods, etc.
FC078100484, with a required downtime of 0,5 hours, is free of charge.
Please contact your local Philips representative, for further details.
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| Athorized Representative/Importer/Distributor: | Philips Healthcare Saudi Arabia Ltd. |
| Report Source: | NCMDR |
| Source Ref. Number: | 4FE2C83D7F2B5 |
| 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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