Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 47

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 47
---
 of which we become aware within the prescribed timeframe. We may also fail to recognize that we have become aware of a reportable
adverse event, especially if it is not reported to us as an adverse event or if it is an adverse event that is unexpected or removed in
time from the use of the product. If we fail to comply with our reporting obligations, the FDA could take action, including warning letters,
untitled letters, administrative actions, criminal prosecution, imposition of civil monetary penalties, revocation of our device clearance,
seizure of our products or delay in clearance of future products.

  27  

The FDA and foreign regulatory bodies have the authority
to require, and in the United States companies are expected to voluntarily implement, the recall of commercialized products in the event
of material deficiencies or defects in design or manufacture of a product or in the event that a product poses an unacceptable risk to
health. An FDA recall, whether mandatory or voluntary, may be based on a finding that there is reasonable probability that the device
could cause serious injury or death. A government mandated or voluntary recall by us could occur as a result of an unacceptable risk to
health, component failures, malfunctions, manufacturing defects, labeling or design deficiencies, packaging defects or other deficiencies
or failures to comply with applicable regulations. Product defects or other errors may occur in the future. If we initiate a correction
or removal for one of our devices to reduce a risk to health posed by the device, we would be required to submit a publicly available
Correction and Removal report to the FDA and, in many cases, similar reports to other regulatory agencies. This report could be classified
by the FDA as a device recall which could lead to increased scrutiny by the FDA, other international regulatory agencies, and our customers
regarding the quality and safety of our devices. Furthermore, the submission of these reports could be used by competitors against us
in competitive situations and cause customers to delay purchase decisions or cancel orders and would harm our reputation.

Depending on the corrective action we take to redress
a product’s deficiencies or defects, the FDA may require, or we may decide, that we will need to obtain new authorization for the
device before we may market or distribute the corrected device. Seeking such authorization may delay our ability to replace the recalled
devices in a timely manner. Moreover, if we do not adequately address problems associated with our devices, we may face additional regulatory
enforcement action, including FDA untitled letters or warning letters, product seizure,