FDAClass IISeptember 14, 2016

Centricity Enterprise Archive is a software product for recall

Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install…

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

There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. In an unlikely event that the cache disk is almost full (<100MB) and HL-7 update events are received, the update action fails and an empty path name is written to the EA database. As a result the instance is not deleted from the storage device but no longer referenced. When trying to retrieve the instance an error is returned.

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?

Version: 3.0.x

Product
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install…
Recalling firm
Ge Healthcare It
Quantity
1,379 units
Distribution
Nationwide Distribution
Recall date
September 14, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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