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U.S. Department of Health and Human Services

Class 2 Device Recall NaviCare

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  Class 2 Device Recall NaviCare see related information
Date Initiated by Firm April 13, 2022
Create Date May 13, 2022
Recall Status1 Terminated 3 on December 20, 2023
Recall Number Z-1093-2022
Recall Event ID 89961
Product Classification System, communication, powered - Product Code ILQ
Product NaviCare Nurse Call

System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
Code Information Internal Part Number: 3.9.; UDI/GTIN: 00887761985209; P2519NNC3A24 model number of impacted RubyTech Switch
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 Firm discovered a firmware memory leak with a supplier-manufactured component.
FDA Determined
Cause 2		 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 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
Quantity in Commerce 11028 units
Distribution US Distribution to states of: NC and VA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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