FDAClass IIIAugust 29, 2012

Sunquest Encompass The reporting site is using the recall

Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.

Why was Sunquest Encompass The reporting site is using the recalled?

Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than the actual collect time only when Daylight Saving Time is active.

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?

versions 2.4 and later

Product
Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.
Recalling firm
Sunquest Information Systems, Inc.
Quantity
23 clients
Distribution
Worldwide distribution: USA (nationwide) and country of: Bahamas.
Recall date
August 29, 2012
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls