Date Initiated by Firm |
April 13, 2022 |
Create Date |
May 13, 2022 |
Recall Status1 |
Terminated 3 on December 20, 2023 |
Recall Number |
Z-1094-2022 |
Recall Event ID |
89961 |
Product Classification |
System, communication, powered - Product Code ILQ
|
Product |
Voalte Nurse Call
System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls. |
Code Information |
Internal Part Number: 4.0.; UDI/GTIN: 00887761995079; 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 |
1414 units |
Distribution |
US Distribution to states of: NC and VA. |
Total Product Life Cycle |
TPLC Device Report
|
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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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