—#104360

Product

Philips BV Endura Fluoroscopic Image Intensified X-ray Catalog Number: 718074 Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system.

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K010435
Affected lot / code info: Shipped from June~2010 to 26 Jul 2011 S/N: 1413 1438 1492 1504 1567 1567 1620 1633 1634 1691 1765 1800

Why it was recalled

Front plate broke in to two pieces causing the C-Arm to suspend on the single central bolt

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-10-04
Posted by FDA: 2011-10-27
Terminated: 2017-01-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104360. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.