GE recalls hundreds of baby 'warmers' in China over safety fears
SHANGHAI (Reuters) - A healthcare unit of General Electric Co has recalled hundreds of incubator-like infant "warmers" in China over safety concerns as Beijing tightens oversight of the country's fast-growing medical device sector.
GE Healthcare recalled 223 of the U.S.-produced 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 cot-like warmers are used in hospitals to regulate the body temperature of tiny infants unable to keep themselves warm due to a lack of body fat. The devices also regulate airflow and monitor vital signs.
The recall announcement coincides with tough messages from China's Cabinet this week that the government would increase oversight and fines in the medical device sector to address safety concerns.
The crackdown could intensify the challenge for international medical device makers such as UK-based GE Healthcare, as well as rivals Siemens AG and Medtronic Inc, as they look to tap into the sector. The Chinese market is estimated to double to more than $50 billion by 2020, according to research firm Global Data.
Chinese firms who fail to meet the tougher regulations could also be forced out of business, consolidating the industry and strengthening larger local players, analysts said.
GE Healthcare has issued a warning note to clients about the problem and will replace the affected units free-of-charge, said the CFDA, which is overseen by the country's Cabinet.
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.
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. Continued...