Philips Medical Systems, Inc. Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Brand
Philips Medical Systems, Inc.
Lot Codes / Batch Numbers
Model Number: Integris Allura 15-12 Serial Number: 16741023
Products Sold
Model Number: Integris Allura 15-12 Serial Number: 16741023
Philips Medical Systems, Inc. is recalling Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system due to Philips had discovered through a field service testing where a device failed to comply with a Federal standard.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Philips had discovered through a field service testing where a device failed to comply with a Federal standard.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL
Page updated: Jan 10, 2026