FDAClass IIDecember 11, 2013

The GE Centricity Web recall

The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity…

Why was The GE Centricity Web recalled?

GE Healthcare has become aware of an issue associated with rejected images using the WADO protocol within GE Centricity Web that may impact patient safety. The WADO (Web Access to DICOM Objects) interface allows for embedding DICOM images as JPEGs on a web page and is available as a licensed operation on Centricity Web. When rejected images are archived by Centricity PACS to Enterprise Archive, an

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: 3.0.x

Product
The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity…
Recalling firm
Ge Healthcare It
Quantity
53 units
Distribution
US Distribution incluidng states of: CA, FL, GA, IA, IL, LA, MO, NJ, NY, OK, TN, WA, and WI.
Recall date
December 11, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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