Philips BV Pulsera Fluoroscopic Image Intensified X-ray Catalog Number: 718095 Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system.
Recall
- Recall Number
- Z-0116-2012
- Event Number
- 60064
- Firm
- Philips Healthcare Inc.
- FEI Number
- 1218950
- Product Code
- JAA
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- October 4, 2011
- Posted
- October 27, 2011
- Terminated
- January 12, 2017
- Address
- 3000 Minuteman Road, Andover, MA, 01810
Description
Philips BV Pulsera Fluoroscopic Image Intensified X-ray Catalog Number: 718095 Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system.
Front plate broke in to two pieces causing the C-Arm to suspend on the single central bolt
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.
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.
134 units in the US