FDAClass IIDecember 31, 2014

Centricity Enterprise Archive is a software product for recall

Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities…

Why was Centricity Enterprise Archive is a software product for recalled?

GE Healthcare has become aware of a potential data loss issue associated with empty path names resulting from HL-7 updates when the cache disk is almost full.

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?

Centricity Enterprise Archive versions: 4.0.x

Product
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities…
Recalling firm
Ge Healthcare It
Quantity
115 units
Distribution
Nationwide Distribution including AZ, OH, WA.
Recall date
December 31, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls