Health technology company Philips is suspending the manufacture of some defibrillators in the US and will make others under heightened scrutiny following criticisms from US regulators.
The Dutch company said the move would dent its profits.
Philips said it expected a hit of €20m to earnings before interest, taxes and amortisation (EBITA) in the fourth quarter of 2017, and a €60m impact for the whole of 2018.
The company made €2.2 billion of EBITA in 2016.
"Philips defibrillators currently in use by customers are recommended by Philips to remain in use, and should not be taken out of service as Philips has no reason to believe they pose a risk to patients," it said.
The US Food and Drug and Administration (FDA) has been raising concerns about defibrillators, which use an electric shock to restore a malfunctioning heart's rhythm, since at least 2013.
Philips disclosed details of the current dispute in January, which focuses on "compliance with good manufacturing practice requirements" in and before 2015 at its facilities in Massachusetts and in Washington.
Despite the modest reduction in forecast earnings, the latest announcement may unnerve investors.
Philips issued a similar warning in 2014 about FDA concerns over how it made medical scanners at its factories in Cleveland, Ohio. That eventually led to further profit warnings and two years of production delays.
CEO Frans van Houten said the current situation was "quite different" because Philips had invested in quality control in recent years.
he scanner problems in Cleveland forced product redesigns and changes to the company's supply chain - neither of which were relevant in the current case, Van Houten said.
He said FDA concerns centred on the company being able to document that products had been manufactured correctly.
"We have made tremendous progress since 2015 but that didn't matter," he said. "This is a consequence of past sins."
Van Houten said the impact on earnings would be "limited", as Philips' global defibrillator sales amount to about €300m a year, compared with group sales in 2016 of €24.5 billion.
The company said affected product lines had 2016 sales of around €140m.
In March, the FDA ordered the recall of 47,000 Philips defibrillators manufactured between 2004 and late 2016.
The company will continue making some defibrillator lines, as well as parts, to ensure the products remain publicly available. It will also resume exports of defibrillators from the affected plants "once certain requirements have been met".
Van Houten said manufacturing of the suspended product lines would resume "in the course of 2018," likely in the third quarter.
