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Field Safety Notices (FSN)

When an FSN is required​

A Field Safety Notice (FSN) must be issued whenever an FSCA is undertaken for safety reasons. The FSN informs affected customers — healthcare institutions, distributors, and in some cases patients — of:

  • The safety issue
  • Which devices are affected (lot/serial numbers)
  • The required action
  • How to respond (return process, correction process)
  • MAH contact details

Content requirements​

A Japan-format FSN must include:

  1. Header: "Field Safety Notice" (or "回収のお知らせ" for recalls) — clearly identified as a safety communication
  2. Device identification: brand name, model number, JMDN code, approval/certification number, affected lot/serial numbers
  3. Description of the issue: plain-language description of the defect or safety concern
  4. Risk assessment: what harm could result if the device continues to be used
  5. Required action: precise instructions for what the recipient must do (return, quarantine, stop use, apply software update)
  6. Response deadline: timeline for required action
  7. Response instructions: contact name, telephone number, email, and return address
  8. MAH confirmation: the MAH's name, address, and authorised signatory

Japanese-language obligation​

FSNs distributed to customers in Japan must be provided in Japanese. Bilingual notices (Japanese and English) are acceptable for multinational recalls, but the Japanese text is the operative version for Japan distribution.

Distribution of FSNs​

The FSN must be distributed to all customers who received affected units, based on the MAH's distribution records. For widely distributed consumer devices, this may include direct patient notification. MHLW may require broader distribution or public announcement for significant safety issues.

MHLW publication and escalation

Major recalls (Class I and some Class II recalls) are typically published on the MHLW website within 5 working days of notification. The MAH should be prepared for public visibility of the FSN. For recalls affecting patient safety with high severity, MHLW may issue a separate public safety alert (安全性情報) in addition to the FSN, which may be distributed through healthcare institution networks and published in medical safety bulletins.