SHANGHAI, April 1 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
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
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)