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Pulmonetic Systems Ventilators
Recalled
Pulmonetic Systems is recalling certain LTV series portable ventilators.
The ventilators provide breathing support for adults and children
in home care, hospitals and other institutions. A malfunction may
prevent these ventilators from switching to internal battery operation
when external power is inadequate, a problem that could cause the
device to stop operating. The company is notifying customers and
users about the malfunction and how to correct it.
Full
Story
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Recall of Advanced Bionics Cochlear Implants
Advanced Bionics is recalling all unimplanted CLARION and HiResolution
cochlear implants because moisture in the internal circuitry of
some of these devices may cause them to stop working. Signs of device
failure may include intermittent functioning, sudden sensation of
discomfort or pain, loud noise or complete loss of sound. FDA is
not recommending removal or replacement of devices already implanted
in patients.
Full
Story
Caution
on Use of Enteryx
Boston Scientific has sent a safety alert to health professionals
about the use of Enteryx, a permanently implanted product used to
treat patients with GERD symptoms. Enteryx is a liquid copolymer
that's injected endoscopically into the muscle layer of the lower
esophageal sphincter to help prevent acid reflux. The letter describes
the death of a patient treated with Enteryx and reinforces the importance
of closely following the product directions for use and proper injection
technique.
Full
Story
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Software
for Implanted Infusion Pumps Recalled
Medtronic is recalling certain software application cards used
in the company's Model 8840 N'Vision Clinician Programmers. These
hand-held devices are used to program certain implantable devices,
including the SynchroMed and SychroMed EL implantable infusion pumps.
The recall is prompted by reports of data entry errors that have
led to serious drug overdoses. The company is distributing replacement
software to help reduce the risk of programming errors.
Full
Story
Automatic External Defibrillator Cleared for OTC
FDA recently granted marketing clearance for the first time for
the over-the-counter sale of an automatic external defibrillator
designed specifically for lay users. The HeartStart Home Defibrillator,
manufactured by Philips Medical Systems, was already available with
a prescription for use at home, but can now be purchased without
a prescription.
Full
Story
Safety Tips - Burning Beds
Since 1993, FDA has learned of 95 fires involving electric hospital
beds. Most of the fires were associated with such factors as overheated
bed motors, arcing from ill-fitting plugs, damaged plugs, missing
ground pins, fluid leaks that damaged the circuit boards, missing
components in the wiring, poor maintenance, or failure to heed manufacturers’
warnings.
Burning
Beds
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All Safety Tips
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