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Effective 21 February 2017Respiratory VentilationFSN 86600034A21 February 2017URGENT Field Safety Notice Medical Device Correction V60 Respiratory Ventilator with Version 2.20 Software, False Detection.

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How to fill out the Field Safety Notice Template online

This guide provides comprehensive, user-friendly instructions for completing the Field Safety Notice Template online, ensuring you understand each component of the form. Following these steps will help you successfully acknowledge receipt of important safety information regarding the V60 Respiratory Ventilator.

Follow the steps to complete the Field Safety Notice Template efficiently.

  1. Click ‘Get Form’ button to obtain the form and open it in the editor.
  2. Begin by entering your customer information. Fill in the 'Customer Name', 'Street Address', 'City', 'State', 'Zip Code', and 'Country' fields accurately. Make sure to double-check spelling and completeness.
  3. Next, provide the 'Contact Person' name and 'Telephone Number' for the individual responsible for communication regarding this notice. This ensures timely responses and clarifications.
  4. In the email field, enter a valid 'E-mail' address to receive updates or further information if necessary.
  5. Indicate your understanding of the recall instructions by selecting 'Yes' or 'No' in the 'I have read and understand the recall instructions provided in the January 27, 2017 letter' section.
  6. Address any adverse events that may have occurred. If applicable, select 'Yes' and provide a brief explanation about the incidents related to the recalled product.
  7. In the 'Affected Product Information' section, fill out the serial numbers of all affected products at your site. Ensure each entry is accurate and check for duplicates.
  8. Use the 'Return Response Box' to provide any additional relevant information that may be needed for processing your acknowledgment.
  9. Once all fields are filled out, review the entire form for accuracy. After confirming that the information is correct, save your changes. You can now download, print, or share the completed form as required.

Complete your Field Safety Notice Template online today to ensure compliance and safety.

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A Field Safety Corrective Action is an action taken by a manufacturer to report any technical or medical reason leading to a systematic recall of devices of the same type by the manufacturer to the National Competent Authority.

A 'field safety notice' (FSN) is an important communication about the safety of a medical device that is sent to customers by a device manufacturer, or their representative. FSNs tell you what you need to do to reduce the specified risks of using the medical device.

In other words, the filed safety notice is typically sent to the customers in combination with a field corrective action, that may include a recall or other type of actions on the device ( for example, a software update).

DEFINITION OF A FIELD SAFETY CORRECTIVE ACTION AND A RECALL “Field safety corrective action is an action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market.

The FSCA may include; the return of a medical device to the supplier, device modification, device exchange, device destruction, retrofit by purchaser of manufacturer's modification or design change, advice given by manufacturer regarding the use of the device (e.g. where the device is no longer on the market or has ...

Recall: it is a type of FSN where a manufacturer takes a correction or removal action to address a problem with a medical device, Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Recalls are assigned subjective levels of risk by the reporting agency and may be reported using the following classes listed below. There are three classes of recall used by the FDA and USDA: Class 1, Class 2 and Class 3, often represented with Roman numerals I, II and III respectively.

A field safety notice (FSN) is an important means of communicating a field safety corrective action (FSCA) and related safety information to users. It may also be used to provide updated information about how an IVD should be used.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Help Portal
Legal Resources
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232