Philips Digital Diagnost Stationary radiographic system recall
Philips Digital Diagnost Stationary radiographic system
Why was Philips Digital Diagnost Stationary radiographic system recalled?
When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Digital Diagnost systems with Eleva software version 3.0.x
- Product
- Philips Digital Diagnost Stationary radiographic system
- Recalling firm
- Philips Healthcare Inc.
- Quantity
- 360
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Canada, Chile, Czech republic, Estonia,France, Germany, Hungary, Inida, Ireland, Italy, Japan, Libyan Arab Jamahari, Mexico, Netherlands, New Zealand, Norway , Oman, Panama, Peru, Poland, Qatar, Reunion, Russia, Saudi Arabia, South Africa, South Korea,Spain, Sweden, Swizerland, Thailand, UAE, and the UK.
- Recall date
- March 13, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)