Philips BV Endura Fluoroscopic Image Intensified X-ray Catalog Number: 718074 Product Usage: Fluoroscopic x-ray system,
FDA device recall Z-0117-2012 · posted 2011-10-27 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- Front plate broke in to two pieces causing the C-Arm to suspend on the single central bolt
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 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, Ru
- Date initiated
- 2011-10-04
- Date posted
- 2011-10-27
- Date terminated
- 2017-01-12
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS BV PULSERA/ENDURA (K010435) | Philips Medical Systems, Inc. | 2001-03-12 |