Philips Announces Recall For Nuclear Imaging System

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Philips Announces Recall For Nuclear Imaging
System
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By Vikki Harmonay
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Due to potential patient safety concerns, Philips
has announced a recall of its BrightView SPECT
(single-photon emission computed tomography)
imaging device in both the X and XCT versions.
Philips BrightView SPECT The systems detector
could move downward under certain circumstances,
thanks to the failure of a screw which could lead
the device to fall on a patient. The U.S. Food
and Drug Administration has designated this as a
Class I recall, which is the most serious level
of recall. It means that the issue could result
in serious adverse health consequences or death.
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In its notice issued Feb. 2, the FDA said, If
the detector is positioned below center of
gravity, there is a potential for abrasion,
contusion, laceration and/or fracture to the
patients lower limbs, as well as an interruption
to normal system operation. If the detector is
positioned above the center of gravity, there may
be an interruption to normal system
operation. In December, Philips first started
notifying customers about the potential danger.
It was in response to one complaint the company
received in 2023 as part of its regular
surveillance activities. No patients have been
injured or harmed.
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The BrightView systems may continue to be used
in accordance with their instructions for use and
the instructions in the field safety notice,
Philips said in an email sent to the media.
Philips is contacting customers to schedule an
inspection of the system. Implementation of an
additional safety mechanism, and if necessary,
replacement of the leadscrew. Headquartered in
Amsterdam, Philips stopped producing and selling
the BrightView SPECT family of produces in 2014.
The safety notice will cover the remaining 1,000
imaging systems that are still being used. A
Class II recall notice was announced by the
Australian Therapeutic Goods Administration in
January as well.
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Headquartered in Amsterdam, Philips stopped
producing and selling the BrightView SPECT family
of produces in 2014. The safety notice will cover
the remaining 1,000 imaging systems that are
still being used. A Class II recall notice was
announced by the Australian Therapeutic Goods
Administration in January as well. Customers
have been instructed by Philips not to position
patients lower limbs directly under the detector
below the center of the gantry bore. Device
owners are encouraged to contact the Philips
customer care solutions center at 800-722-9377.
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Talk To An Expert If you have questions about
your medical imaging equipment, dont hesitate to
reach out to the experts at Atlantis
Worldwide. Contact Us Today!
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