Z-0022-2015Class II

Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system

Name: Z-0022-2015 Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Creator: Philips Medical Systems, Inc.
Published: 2014-08-08
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-08-08 / Terminated

FDA source

Philips Medical Systems, Inc. began a recall of Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system on 2014-08-08. FDA classified it as Class II and gives the reason as "Philips had discovered through a field service testing where a device failed to comply with a Federal standard". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0022-2015
Classification: Class II
Status: Terminated
Initiated: 2014-08-08
Posted: 2014-10-09
Terminated: 2014-12-03
Recalling firm: Philips North America LLC
Product: Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Philips had discovered through a field service testing where a device failed to comply with a Federal standard.
FDA root cause: Radiation Control for Health and Safety Act
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.
Quantity in commerce: one system
Distribution: US distribution to FL
Product codes and lots: Model Number: Integris Allura 15-12 Serial Number: 16741023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0022-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0022-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-09

Product code OWB

K002016Class IIPhilips Integris AlluraPhilips Medical Systems North America, Inc. / cleared 2000-09-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)