Z-0117-2012

Philips BV Endura Fluoroscopic Image Intensified X-ray Catalog Number: 718074

Name: Z-0117-2012 Philips BV Endura Fluoroscopic Image Intensified X-ray Catalog Number: 718074
Creator: Philips Healthcare Inc.
Published: 2011-10-04
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-10-04 / Terminated / root cause: manufacturing process

FDA source

Philips Healthcare Inc. began a recall of Philips BV Endura Fluoroscopic Image Intensified X-ray Catalog Number: 718074 Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray... on 2011-10-04. The reason FDA records is "Front plate broke in to two pieces causing the C-Arm to suspend on the single central bolt". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0117-2012
Status: Terminated
Initiated: 2011-10-04
Posted: 2011-10-27
Terminated: 2017-01-12
Recalling firm: Philips North America LLC
Product: Philips BV Endura Fluoroscopic Image Intensified X-ray Catalog Number: 718074 Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Front plate broke in to two pieces causing the C-Arm to suspend on the single central bolt
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Philips Healthcare Inc., sent an "URGENT - Field Safety Notice" dated September 30, 2011 to all affected customers. The notice identifies the following: what the problem is and under what circumstances it can occur; the actions that should be taken by the customer/user in order to prevent risks for patients or users and the actions planned by Philips Medical Systems to correct the problem. The notice contains important information for the continued safe and proper use of the equipment and customers were advised to retain a copy with the equipment Instruction for Use. The notice stated that Philips will replace the front plates for systems on the Unit Affected List by the end of June 2012. The notice instructed customers to contact Philips Healthcare representative for further information or support.
Quantity in commerce: 12 units in the US
Distribution: Worldwide Distribution - USA (nationwide) and the countries of: Australia, Austria, Belgium, Bharain, Canada, Croatia, Denmark, France, Germany, Greece, Italy, Japan, Netherlands, Norway, Portugal, Russian Fed., Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
Product codes and lots: Shipped from June~2010 to 26 Jul 2011 S/N: 1413 1438 1492 1504 1567 1567 1620 1633 1634 1691 1765 1800

Product code JAA

K010435Class IIPhilips Bv Pulsera/enduraPhilips Medical Systems, Inc. / cleared 2001-03-12

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)