Recalls / —

—#129837

Product

Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system

FDA product code

OWB — Interventional Fluoroscopic X-Ray System

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K002016

Affected lot / code info

Model Number: Integris Allura 15-12 Serial Number: 16741023

Why it was recalled

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

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm

Philips Medical Systems, Inc.

Address

3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern

US distribution to FL

Timeline

Recall initiated

2014-08-08

Posted by FDA

2014-10-09

Terminated

2014-12-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #129837. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.