Philips Electronics North America Corporation Recall: Allura Xper systems with Certeray X-
Philips Electronics North America Corporation Recall: Allura Xper systems with Certeray X- is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Philips Electronics North America Corporation; Product: Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V)
| Recalling firm | Philips Electronics North America Corporation |
|---|---|
| Product | Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: 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 placin |
| Reason for recall | There is an increase in the failure rate of certain Anode Drive Units (ADU5) used in these products. 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 also 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 |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - US Nationwide; foreign distribution to Brazil, Germany, Iceland, Japan, Mexico, and (updated 6/25/18) Saudi Arabia. |
| Recall initiated | 20180104 |
| Recall number | Z-0716-2018 |
| Category | device |
| State | MA |
| Country | United States |
$29/mo
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