SHANGHAI, April 1 (Reuters) - A unit of General Electric Co has recalled hundreds of infant “warmers” in China over safety concerns as Beijing tightens oversight of the fast-growing medical device sector.
GE Healthcare is recalling 223 of the high-tech warmers after uncovering a potential safety issue that could restrict oxygen supply to the child, the China Food and Drug Administration (CFDA) said in a statement on Tuesday.
The recalled warmers - cots designed to regulate body temperature and airflow to newborn babies - include “Panda” and “Giraffe” branded warmers. The devices were manufactured outside China, according to GE Healthcare China.
China said this week it would toughen oversight and fines in the medical device sector as it looks to address safety concerns. That raises the bar for international firms looking to quickly enter the market, which may double to more than $50 billion by 2020, according to research firm Global Data.
GE Healthcare has issued a warning note to clients about the problem and will replace the affected goods free-of-charge, the CFDA said.
Neither party gave a total value of the recalled goods, but infant warmers can cost anywhere from a few thousands dollars to more than $20,000 per unit.
GE Healthcare’s China unit said in an emailed statement that it had moved “swiftly to resolve the issue” and acted in accordance with Chinese laws and regulations.
“No patient injuries have been reported,” GE Healthcare said in the statement.
The CFDA said the oxygen and air fittings on the back panel of the warmers had been reversed in some cases during assembly, which could prevent the efficient regulation of air and oxygen flow to the infant. This could lead too little or too much oxygen being delivered to the child, a potentially fatal issue.
GE has been forced to recall similar products in other markets including the United States, where it recalled warmers and resuscitation units late last year because of issues with the supply of oxygen to the baby, according to the U.S. Food and Drug Administration.
GE started the voluntary recall earlier this month after identifying the potential safety issue, and it has already taken measures to resolve it, the CFDA said.
Medical device makers in China have drawn the glare of regulators before, hit by allegations of corruption and bribery. Some firms were also targeted last year for overpricing. (Reporting by Adam Jourdan; Editing by Ryan Woo)