—#192992

Product

Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.

FDA product code: ILQ — System, Communication, Powered
Device class: Class 2
Medical specialty: Physical Medicine
Affected lot / code info: Internal Part Number: 4.0.; UDI/GTIN: 00887761995079; P2519NNC3A24 model number of impacted RubyTech Switch

Why it was recalled

Firm discovered a firmware memory leak with a supplier-manufactured component.

Root cause (FDA determination)

Software design

Action the firm took

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 william.knouse@hillrom.com. 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 william.knouse@hillrom.com

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US Distribution to states of: NC and VA.

Timeline

Recall initiated: 2022-04-13
Terminated: 2023-12-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192992. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.