Recall Z-0116-2012 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips Healthcare Inc.
Philips BV Pulsera Fluoroscopic Image Intensified X-ray Catalog Number: 718095 Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system.
| Date | Oct 27, 2011 (initiated Oct 4, 2011) |
| Status | Terminated |
| Reason | Front plate broke in to two pieces causing the C-Arm to suspend on the single central bolt |
| 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 Ph |
| Quantity | 134 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010435 | PHILIPS BV PULSERA/ENDURA Philips Medical Systems, Inc., Mar 12, 2001 |