The agency cited the manufacturer for distributing new sleep sack sizes and a clinical bassinet bundle without required clearance, alongside quality system and reporting violations.
A study by a Nemours Children's Health researcher finds 1 in 4 deaths of prenatally exposed infants involved caregivers who were both impaired and bed-sharing at the infant's time of death.
Amid a massive recall in 2021, the medical device maker Philips raced to overcome troubling questions about its replacement machines as customers waited for help.
Unsafe sleep practices underlie most sudden unexpected infant deaths in the US, with three-quarters of infants affected by multiple unsafe practices at the time of death.
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New research suggests genetic testing at birth may hold the promise of detecting sudden infant death syndrome risk—and potentially other causes of sudden death later in life.
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A study uncovers mothers’ tendency to deviate from the American Academy of Pediatrics’ safe sleep recommendations, citing them as unrealistic.
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There were multiple unsafe sleep practices at play in more than three-quarters of sudden unexpected infant deaths reported in 23 jurisdictions between 2011 and 2020, a new study reveals.
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Sleep Technologies has issued a recall for its Eco Terra Hybrid Latex Mattresses over concerns of a potential fire hazard.
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Lock socket, a solution for securing electrical cords, provides enhanced power protection for various devices, including CPAP machines.
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The sleep planner tool is a new way to find out about babies’ risks and help keep them safe while sleeping.
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Home Design has received 128 reports of the beds breaking, sagging, or collapsing, including 36 injuries.
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Using video evidence, researchers uncover a potential cause for sudden unexplained deaths in children, which usually occur during sleep.
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Researchers surveyed scientific studies on co-sleeping, revealing a polarizing debate between its risks and benefits.
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Philips raised its 2023 earnings outlook following an uptick in third-quarter sales, despite ongoing challenges related to its CPAP and ventilator device recall.
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US Senator Dick Durbin and US Representative Jan Schakowsky have introduced legislation to reform medical device recalls in an effort to improve patient safety.
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Sen. Richard Blumenthal is calling for “immediate, aggressive action” against Philips for keeping known defects with the company’s CPAP machines secret.
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Philips Respironics says it plans to conduct additional testing on certain CPAP and respiratory devices involved in its June 2021 recall at the request of the FDA.
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ProPublica and the Pittsburgh Post-Gazette have filed suit against the US Food and Drug Administration, accusing the agency of holding back records related to the recall of breathing machines.
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