Z-1554-2020Class II

NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety)...

Name: Z-1554-2020 NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety)...
Creator: Hill-Rom Inc.
Published: 2020-02-14
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2020-02-14 / Terminated / root cause: software

FDA source

Hill-Rom Inc. began a recall of 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... on 2020-02-14. FDA classified it as Class II and gives the reason as "There is a software issue which may result in failure to monitor or control patient's bed exit mechanism". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1554-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-14
Posted: 2020-03-22
Terminated: 2021-02-11
Recalling firm: Hill-Rom Inc.
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)
Product code: KMI Monitor, Bed Patient
Reason for recall: There is a software issue which may result in failure to monitor or control patient's bed exit mechanism.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: The firm issued a Urgent Medical Device notification on 02/14/2020 by letter. The letter identified the reason and requested the following actions be taken: 1. Hillrom is recommending customers disable the NPS software module, including monitoring for Bed Exit Not Armed, to avoid the potential for staff being unaware of the bed exit state. 2. With the NPS software disabled, caregivers will need to return to manually arming the bed exit to alert for patients exiting the bed. Hillrom is developing a software update for NaviCare Patient Safety and anticipates availability in April 2020. Next Steps: Hillrom will be reaching out to assist you with disabling the software module and plan your upgrade. If you have any questions, or would like to proactively schedule an upgrade, please contact Hillrom Technical Support at 1-800-445-3720, option 3 (Cary), option 1 (NaviCare Nurse Call).
Quantity in commerce: 35 Software Systems
Distribution: Colorado, Georgia, Indiana, Louisiana, North Carolina, Nevada, Oregon, South Carolina, Tennessee, Virginia, Washington.
Product codes and lots: NaviCare Patient Safety Software versions 3.5.400 to 3.9.300

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1554-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1554-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-22

Product code KMI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)