Recall Z-1283-2012 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips Medical Systems Gmbh, DMC
Philips Easy Diagnost Eleva DRF, Software release 4.0 Fluoroscopic image-intensified Stationary X-Ray System.
| Date | Mar 23, 2012 (initiated Mar 9, 2012) |
| Status | Terminated |
| Reason | Underexposed image due to lag in switching between auxiliaries |
| Root cause | Software design |
| Action | Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated February 27, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The firm provided a work around for customers to use until a software update can be installed. Customers should contact their local Philips representative for questions regarding this notice. |
| Quantity | 88 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Australia, Germany, Indonesia, Malaysia, Saudi-Arabia, Singapore, and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031535 | PHILIPS EASYDIAGNOST ELEVA Philips Medical Systems North America Co., Jun 17, 2003 |