Philips North America Llc: The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. "Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implanatations, and electrophysiology (EP). "Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures."

Recall number

Z-2474-2021

Recalling firm

Philips North America Llc

Product

The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. "Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implanatations, and electrophysiology (EP). "Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures."

Status

Terminated

Initiated

2021-08-13

Posted

not on file

Terminated

2024-03-11

Reason

Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulated-gate bipolar transistor) of the ADU. The overheating may generate a peculiar burning smell that may be noticed. In some instances, this burning smell may be noticed before the ADU fails. When the ADU fails the X-ray performance of the system is reduced to Emergency Fluoroscopy. Exposure will not be possible and image quality will be reduced.

Root cause

Device Design

Action

Philips notified accounts by Urgent Medical Device Recall letter via certified mailing United States Postal Service (USPS) on 8/13/21. Letter states reason for recall, health risk and action to take: Please place this Medical Device Recall letter with the documentation of the system until this correction has been implemented in your system. Additionally, please return the attached reply form to Phhilps to confirm that the users of the system have reviewed and understood this Medical Device Recall. Philips will correct the affected systems by replacing the ADUs. A Philips service representative will contact you to schedule the correct ion of your system. Please be assured that maintaining a high level of safety and quality is our highest priority. lf you need any further information or support concerning thls issue, please contact your local Philips representative: 1-800-722-9377 (reference FCO72200483

Quantity

4 units

Distribution

US Nationwide distribution in the states of ID, MA, MI, TX, VA.

Lot, serial or model codes

Serial numbers: 48, 66, 67, 160

510(k) numbers

["K141979"]

PMA numbers

not on file

Product code

OWB

Firm FEI

3016618143

Firm city

Cambridge

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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