Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 recall
Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and…
Why was Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 recalled?
Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations
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?
Software Versions: MDC PACS R2.2; R2.3 IntelliSpace PACS DCX R3.1
- Product
- Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and…
- Recalling firm
- Philips Medical Systems, Inc.
- Quantity
- 373 units
- Distribution
- Worldwide Distribution - US Distribution including Puerto Rico and the states of CA, FL, IL, NJ, OK and WA., and the countries of : Argentina Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Bosnia, Brazil, Bulgaria, Chile, China, Egypt, Ethiopia, France, Germany, Ghana, Greece, Guinea, India, Iraq, Israel, Italy, Latvia, Libya, Lithuania, Malawi, Malta, Mexico, Mozambique, Nepal, New Zealand, Papua, New Guinea, Paraguay, Philippines, Poland, Portugal, Romania, Russia, Slovakia, Slovenia, Solomon Islands, South Africa, Spain, Thailand, Turkey, United Arab Emirates and United Kingdom.
- Recall date
- April 30, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)