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Get the free Field Safety Notice: 25 to 29 March - GOV.UK

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March X, 2019 Olympus reference: OIL 151011URGENT FIELD SAFETY NOTICE NEW OPERATING AND REPROCESSING INSTRUCTIONS FOR THE OLYMPUS TJF260V & JF260V DUODENOVIDEOSCOPESAttention: Operating Room Manager,
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01
To fill out Field Safety Notice 25, follow these steps:
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Start by filling out the header section of the form, which includes your contact information, the date, and other relevant details.
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Next, provide a brief description of the safety issue or concern that prompted the notice.
04
Clearly identify the product or device affected by the safety notice, including any specific model or serial numbers if applicable.
05
Specify the actions that need to be taken by the recipient of the notice, whether it's a healthcare professional, distributor, or customer.
06
If necessary, provide additional instructions or guidance on how to address the safety issue, including any recommended corrective actions or precautions.
07
In the closing section, include any contact information or references for further questions or assistance.
08
Make sure to review the completed form for accuracy and completeness before submitting it.
09
Finally, distribute the filled-out Field Safety Notice 25 to the relevant recipients as per the applicable regulations and guidelines.

Who needs field safety notice 25?

01
Field Safety Notice 25 is typically required by manufacturers, distributors, or suppliers of medical devices or other products when there is a safety issue or concern identified with their products.
02
Healthcare professionals, including doctors, nurses, and other medical staff, may also need to be notified and provided with Field Safety Notice 25 if they have previously purchased or used the affected products.
03
Regulatory authorities and agencies responsible for monitoring and ensuring the safety of medical devices or products may also require the submission of Field Safety Notice 25 for reporting and tracking purposes.
04
Ultimately, anyone involved in the distribution, use, or management of the product in question may need Field Safety Notice 25 to ensure proper awareness and action regarding the identified safety issue.
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Field safety notice 25 is a notification that must be submitted to regulatory authorities by manufacturers, importers, or distributors when a medical device poses a risk to the health and safety of patients, users, or others.
Manufacturers, importers, or distributors of medical devices are required to file field safety notice 25.
Field safety notice 25 typically requires information such as device details, risk assessment, actions taken, and contact information. It is important to follow the specific guidelines provided by the regulatory authorities.
The purpose of field safety notice 25 is to inform regulatory authorities about any potential risks associated with a medical device and to propose actions to mitigate these risks.
Information that must be reported on field safety notice 25 includes details about the device, the identified risk, the affected batch or serial numbers, the proposed actions, and contact information for further communication.
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