FDAClass IIMay 29, 2013

LATITUDE¿ Patient Management System recall

LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with…

Why was LATITUDE¿ Patient Management System recalled?

Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3 because between March 4 and 27, 2013, a Siebel release caused ~5000 distributed PMR clinic faxes to display with illegible characters and not the required, Patient non-compliance information that was intended.

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?

n/a

Product
LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with…
Recalling firm
Boston Scientific CRM Corp
Quantity
1
Distribution
Nationwide Distribution including DC and PR
Recall date
May 29, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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