FDAClass IISeptember 2, 2015

Centricity PACS-IW with Universal Viewer Product Usage recall

Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system…

Why was Centricity PACS-IW with Universal Viewer Product Usage recalled?

Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1.

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?

Model Number: Centricity PACS-IW with Universal Viewer Version 5.0 through 5.0 SP7 Codes: 2090255-001 UV 6.0 Web Client Media Kit. 05 Jun 15 to present

Product
Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system…
Recalling firm
GE Healthcare
Quantity
82 systems
Distribution
Worldwide Distribution - U.S. nationwide in the states of: AK, CA, CO, DE, FL, HI, ID, NY, PA, SD, TN and TX; France, Germany, Greece, India, Israel, Malaysia, Mexico, Northern Ireland (UK), Panama, Poland, Russia, South Africa, Saudi Arabia, Switzerland, Turkey, UAE and Uruguay.
Recall date
September 2, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls