|GE's Giraffe infant warmer-- Courtesy of GE Healthcare|
A GE Healthcare ($GE) unit recalled hundreds of infant resuscitation devices in China after uncovering potential safety issues. The recall coincides with China's latest regulatory action, which calls for more stringent oversight of medical device makers.
The Medford, MA-based company pulled 223 of its Giraffe and Panda infant warmers after discovering a manufacturing error that could restrict oxygen to the child, Reuters reported. Warmers are designed to monitor vital signs in infants and newborns and regulate body temperature. The China Food and Drug Administration (CFDA) told Reuters that oxygen and air fittings on the back panel of some of the warmers had been reversed during assembly, which could interfere with air and oxygen flow to the infant--a potentially fatal issue.
Neither GE nor the CFDA gave a total value of the recalled goods, but the company's China unit told Reuters in an emailed statement that it had moved "swiftly to resolve the issue." GE also issued a warning note to clients about the problem and will replace the affected warmer systems free of charge.
"While site inspections are still ongoing, to date no reversion has been found in inspected units in China, and no patient injuries have been reported," the company said in a statement.
The recall comes on the heels of new regulatory action from Chinese authorities. Lawmakers recently passed new rules governing sales and manufacturing of medical devices, providing a major overhaul to outdated legislation and increasing punishment for corporate malpractice. The rules were meant to crack down on corruption within the industry and regulate the country's rapidly growing device sector: The market currently stands at around $20 billion and is expected to grow at up to 20% annually over the new few years, according to McKinsey & Co. Companies like GE, Medtronic ($MDT) and Covidien ($COV) are vying for a piece of the pie but face closer scrutiny from the nation's top authorities.
This is not the first time GE has faced regulators' ire for its infant warmer systems. In December 2012, the FDA slapped the company with a Class I recall--its more serious designation--for malfunctioning T-piece circuits used with its Panda and Giraffe devices. The company took "voluntary field corrective action" in February 2013 for its infant resuscitation systems after it found that oxygen and air wall inlet fittings and/or labels on the back panel could have been reversed during assembly.
- read the Reuters article