Philips Recalls Allura Xper Systems Due to Anode Drive Unit Failure
Philips is recalling 705 Allura Xper systems because Anode Drive Units may fail in high-voltage regions, reducing X-ray performance to emergency mode.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (reduced diagnostic capability and potential overheating) without reported injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Electronics North America Corporation is recalling 705 Allura Xper systems equipped with Certeray X-ray Generators. The recall affects systems located in regions with high mains voltage (480V) and includes specific model numbers 722026 through 722079, as well as model 1120. The products were distributed nationwide in the US and in Brazil, Germany, Iceland, Japan, Mexico, and Saudi Arabia.
The recall is due to an increased failure rate of the Anode Drive Units (ADU5). In 480V environments, the voltage can cause the coils protecting the insulated-gate bipolar transistors to saturate and overheat. This overheating may produce a burning smell before the unit fails. When the ADU fails, the system's X-ray performance is reduced to Emergency Fluoroscopy, meaning standard exposure is not possible and image quality is degraded.
Healthcare facilities should contact Philips to arrange for inspection and repair of the affected units. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- 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
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 705
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- Allura Xper systems - Model #'s 722026
- 722027
- 722028
- 722029
- 722033
- 722034
- 722035
- 722036
- 722038
- 722039
- 722058
- 722059
- 722063
- 722064
- 722065
- 722066
- 722078
- 722079
- (added as of 6/25/2018) 1120
Distribution
Distributed nationwide across the United States.
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