FDA Recall
Terminated
Philips Easy Diagnost Eleva DRF, Software release 4.0 Fluoroscopic image-intensified Stationary X-Ray System.
Recall: Z-1283-2012
·
Initiated March 9, 2012
Recall
- Recall Number
- Z-1283-2012
- Event Number
- 61365
- Firm
- Philips Medical Systems Gmbh, DMC Development and Manufacturing Ctr. Roentgenstrasse 24 Hamburg Germany
- FEI Number
- 3003768251
- Product Code
- JAA
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- March 9, 2012
- Posted
- March 23, 2012
- Terminated
- May 23, 2013
Description
Philips Easy Diagnost Eleva DRF, Software release 4.0 Fluoroscopic image-intensified Stationary X-Ray System.
Reason
Underexposed image due to lag in switching between auxiliaries
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.
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Australia, Germany, Indonesia, Malaysia, Saudi-Arabia, Singapore, and Thailand.
Quantity
88 units