Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 564

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 564
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 which
the manufacturer has its registered place of business.

Under the EU MDR, a “serious
incident” means any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death
of a patient, user or other person; (b) the temporary or permanent serious deterioration of a patient’s, user’s or other person’s
state of health; or (c) a serious public health threat. A “field safety corrective action” means corrective action taken by
a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available
on the market.

Malfunction of our products could
result in future voluntary corrective actions, such as recalls, including corrections, or customer notifications, or agency action, such
as inspection or enforcement actions. If malfunctions do occur, we may be unable to correct the malfunctions adequately or prevent further
malfunctions, in which case we may need to cease manufacture and distribution of the affected products, initiate voluntary recalls, and
redesign the products. Regulatory authorities may also take actions against us, such as ordering recalls, imposing fines, or seizing the
affected products. Any corrective action, whether voluntary or involuntary, will require the dedication of our time and capital, distract
management from operating our business, and may harm our reputation and financial results.

Our approved product or product candidates may
in the future be subject to product recalls that could harm our reputation, business and financial results.

Medical devices can experience
performance problems in the field that require review and possible corrective action. The occurrence of component failures, manufacturing
errors, software errors, design defects or labeling inadequacies affecting a medical device could lead to a government-mandated or voluntary
recall by the device manufacturer, in particular when such deficiencies may endanger health. The FDA requires that certain classifications
of recalls be reported to the FDA within 10 working days after the recall is initiated. Comparable foreign regulatory authorities impose
similar deadlines. Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA or to comparable
foreign regulatory authorities. We may initiate voluntary recalls involving our products in the future that we determine do not require
notification of the FDA. If the FDA disagrees with our determinations, they could require us to report those actions as recalls. Product
recalls may divert management attention and financial resources, expose us to product liability or other claims, harm our reputation with
customers and adversely