Philips recalled 14 units of the Allura Xper FD10/10 due to a potential electrical hazard. The recall affects medical imaging systems distributed worldwide. If the drip tray beneath the cooling unit is not installed, coolant may contact electrical components, leading to system shutdown.
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. or your healthcare provider for instructions. Notification method: Letter
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The Allura Xper FD10/10 is a medical imaging system used in healthcare settings for diagnostic purposes. Healthcare providers rely on these systems for accurate imaging to assist in patient diagnosis and treatment.
The hazard arises when the drip tray beneath the cooling unit is not installed correctly. This oversight can lead to coolant leaking and potentially contacting electrical components, resulting in dangerous short-circuits.
This recall is not part of a broader industry pattern.
The recall affects a limited number of devices, but the potential for electrical failure could compromise patient safety and lead to system outages in medical facilities.
Serial numbers and model information can typically be found on the device's label or user manual.
Expect a processing timeline of 4-6 weeks for refunds or replacements after contacting Philips.
Keep copies of all correspondence with Philips, including emails and letters, along with any receipts related to the purchase of the device.
The recalled product is the Allura Xper FD10/10, Model Number: 722005. It was distributed worldwide, including the US and various countries. The quantity recalled is 14 units.
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