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Terminated

Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system

FDA Recall Z-0022-2015 · Posted 2014-10-09

Recalling FirmPhilips Medical Systems, Inc.
Recall StatusTerminated
Product CodeOWB
Date Initiated2014-08-08
Date Terminated2014-12-03
Product Quantityone system

Reason for Recall

Philips had discovered through a field service testing where a device failed to comply with a Federal standard.

Firm Action

Philips Healthcare discovered through field service testing, that the device was in violation. Firm service rep. visited site on 7/01/14 and corrected unit. The field service engineer immediately reprogrammed the generator for the X-ray tube installed in the system and re-adapted the x-ray tube to bring the system back into compliance. At this time the Failure to comply has been corrected and the customer has been notified. This correction is to be free of charge to the customer. For further questions please call (978) 687-1501.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US distribution to FL

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002016PHILIPS INTEGRIS ALLURAPhilips Medical Systems North America, Inc. · 2000-09-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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