Z-1093-2022Class II

NaviCare Nurse Call System provides a comprehensive communication and information system that places patient...

Name: Z-1093-2022 NaviCare Nurse Call System provides a comprehensive communication and information system that places patient...
Creator: Baxter Healthcare Corporation
Published: 2022-04-13
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-04-13 / Terminated / root cause: software

FDA source

Baxter Healthcare Corporation began a recall of NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls on 2022-04-13. FDA classified it as Class II and gives the reason as "Firm discovered a firmware memory leak with a supplier-manufactured component". 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-1093-2022
Classification: Class II
Status: Terminated
Initiated: 2022-04-13
Posted: 2022-05-13
Terminated: 2023-12-20
Recalling firm: Baxter Healthcare Corporation
Product: NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
Product code: ILQ System, Communication, Powered
Reason for recall: Firm discovered a firmware memory leak with a supplier-manufactured component.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Hillrom, issued an "Urgent Medical Device Correction Notice", dated 04/13/2022, to impacted consignees via email. The consignee is instructed to identify if they have the impacted product component, Part P2519NNC3A2 and also distribute the notification to personnel as well ensure that the users monitor for system alerts. Notify Hillrom Technical support if there is a loss of connectivity to the nurse call server. Note, error indications will display on multiple user interfaces. Central nurses' stations will state the room(s) is down (disconnected). In patient room(s), graphical audio stations will display clear message stating Station down. Contact Nurse directly . In addition, standard audio stations will have an LED Error state indicator. Complete and return the response form to [email protected]. Hillrom is testing a firmware update for the Power over Ethernet (PoE) switch and anticipates availability in April 2022. Upon receipt of the response form, Hillrom will contact you to schedule an update to your system once firmware is available. If you have any questions regarding this Urgent Medical Device Correction, please contact Hillrom Technical Support at +1 919 854 3361 or [email protected]
Quantity in commerce: 11028 units
Distribution: US Distribution to states of: NC and VA.
Product codes and lots: Internal Part Number: 3.9.; UDI/GTIN: 00887761985209; P2519NNC3A24 model number of impacted RubyTech Switch

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1093-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1093-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-25	2022-05-13
Z-1094-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-25	2022-05-13

Product code ILQ

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)