Recall Z-0985-2012 ยท IZI System, X-Ray, Angiographic
Philips Healthcare Inc.
MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1 Product Code 708036 Product Usage: The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. General R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skele
| Date | Feb 8, 2012 (initiated Jan 9, 2012) |
| Status | Terminated |
| Reason | Incorrect Skin Dose calculation. AKR (Air Kerma Rate) displayed and stored in patient records is too low |
| Root cause | Employee error |
| Action | Philips Healthcare issued a mandatory Urgent Field Safety Noticedated October 3, 2011 to all affected customers. The letter identifies the affected product, problem description, hazard involved, action to be taken by customer/user and actions planned by Philips to correct the problem. The letter provide important information for the continued safe and proper use of the equipment. The letter instructs customers to review the following information with all members of their staff who need to be aware of the contents of this communication and retain a copy with the equipment Instruction for Us |
| Quantity | 10 units (US) |
| Distribution | Worldwide Distribution - USA (nationwide) including the states of CA, IL, OH, SD, TX, WY and the countries of: Australia, Austria, Canada, Egypt, Germany, mexico, Turkey and UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023441 | PHILIPS MULTIDIAGNOST ELEVA Philips Medical Systems, Oct 30, 2002 |