AMSTERDAM (dpa-AFX) - Medical supply company Philips Respironics owned by Koninklijke Philips N.V. (PHGFF.PK) on Wednesday said it has reached an agreement on a consent decree with the U.S. Government.
The consent decree is related to Philips' recall of its certain BiPAP (bi-level positive airway pressure) and CPAP (continuous positive airway pressure) sleep therapy devices and mechanical ventilators in 2021 due to health risks.
In January this year, the main terms of the consent decree had been communicated to Philips Holding USA and Philips Respironics. They have now reached final agreement on this with the DOJ and FDA.
'Philips' subsidiaries Philips Holding USA and Philips Respironics have now reached final agreement on the consent decree with the DOJ and FDA, that primarily focuses on Philips Respironics' business operations in the US, including its manufacturing facilities in Murrysville and New Kensington, its service center in Mount Pleasant and its Respironics headquarters in Pittsburgh in Pennsylvania,' the company said in a statement.
The consent decree has the following deliverables as communicated by Philips in January:
* Philips Respironics will continue to prioritize completing the remediation of the sleep and respiratory care devices under Respironics' voluntary June 2021 recall.
* Philips Respironics' business operations must demonstrate continued compliance with the FDA's Quality System Regulation.
* Philips Respironics will be permitted to continue servicing these sleep and respiratory care devices that are already with healthcare providers and patients, and to sell accessories (including masks), consumables (including patient circuits), and replacement parts (including repair kits).
* Until the relevant requirements of the consent decree are met, Philips Respironics will not resume selling new CPAP or BiPAP devices or other respiratory care devices in the US.
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