Recall Z-1689-2012 ยท IZL System, X-Ray, Mobile
Philips Healthcare Inc.
Philips Practix Convenio Mobile X-ray System Model: 70455 The Practix Convenio is a mains independent motor driven mobile x-ray system, to x-ray body parts of patients to create images for medical diagnostic purposes. The Practix Convenio is intended to x-ray in rooms for medical use.
| Date | May 30, 2012 (initiated May 2, 2012) |
| Status | Terminated |
| Reason | Unexpected Low-level X-ray pulse |
| Root cause | Device Design |
| Action | Philips sent a Urgent Field Safety Notice dated April 26, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to please review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of the communication. Please retain a copy with the equipment instruction for Use. A Philips Service Engineer will contact account as soon as the Field Action Kit is ready to be implemented. Commu |
| Quantity | 10 US; 66 internattional |
| Distribution | Worldwide Distribution-- USA ( nationwide ) including the states of IA, LA, LA, ND, NY, OH and TX and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Germany, Hong Kong, Indonesia, Italy, Malaysia, Mexico, Netherlands, Philippines, Qatar, Russia, Saudi Arabia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042368 | PRACTIX CONVENIO Philips Medical Systems North America Co., Oct 4, 2004 |