FDAClass IIApril 1, 2020

NaviCare Patient Safety Software Versions recall: Software Issue

NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds: 1. VersaCare Revision A-J with upgrade kit Revision K with UCB 1.18 2. Centrella (all versions) 3. Progressa (firmware version 1.15.0.0)

Why was NaviCare Patient Safety Software Versions recalled?

There is a software issue which may result in failure to monitor or control patient's bed exit mechanism.

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?

NaviCare Patient Safety Software versions 3.5.400 to 3.9.300

Product
NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds: 1. VersaCare Revision A-J with upgrade kit Revision K with UCB 1.18 2. Centrella (all versions) 3. Progressa (firmware version 1.15.0.0)
Recalling firm
Hill-Rom Inc.
Quantity
35 Software Systems
Distribution
Colorado, Georgia, Indiana, Louisiana, North Carolina, Nevada, Oregon, South Carolina, Tennessee, Virginia, Washington.
Recall date
April 1, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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