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 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.
This could lead too little or too much oxygen being delivered to the
child, a potentially fatal issue.
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.
"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," GE Healthcare said.
OTHER RECALLS
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.
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GE reported the voluntary recall to Chinese regulators earlier
this month after identifying the potential safety issue, and it has
already taken measures to resolve it, the CFDA said. It had earlier
flagged the potential issue to clients.
The recalled warmers include "Panda" and "Giraffe" branded warmers,
which were manufactured in the United States and imported to China,
GE Healthcare 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.
China's medical products market currently stands at around $20
billion and is expected to grow at up to 20 percent annually over
the next few years, according to McKinsey & Co.
This has attracted firms including Siemens, GE, Koninklijke Philips
NV, Johnson & Johnson and Medtronic, which compete with local
companies such as Mindray Medical International Ltd and China
Resources Wandong Medical Equipment Co Ltd.
An increasing focus on product quality and safety has raised the
regulatory scrutiny firms operate under in the market, which
analysts and lawyers say would spur an industry shake-out.
"At the end, poor and incapable companies will be eliminated, while
large local players can focus their strength on R&D and innovation,
perhaps taking over market share from foreign players," said Jason
Loh, a Shanghai-based medical expert at research firm SmithStreet
Solutions.
(Reporting by Adam Jourdan; editing by Ryan Woo)
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