🔍 RecallPedia

These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Product was rebranded from NaviCare to Voalte in 2020

Class I - Dangerous
🏥 Medical Devices Recalled: October 14, 2021 Hill-Rom Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    All software versions 3.5.400 and above: a. Part Number 3.6, UDI 00887761001541; Part Number 3.7, UDI 00887761021198; Part Number 3.9, UDI 00887761985209 b. Part Number 4.0, UDI 00887761995079
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Hill-Rom Inc.
Reason for Recall:
An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Product was rebranded from NaviCare to Voalte in 2020

Product Codes/Lot Numbers:

All software versions 3.5.400 and above: a. Part Number 3.6, UDI 00887761001541; Part Number 3.7, UDI 00887761021198; Part Number 3.9, UDI 00887761985209 b. Part Number 4.0, UDI 00887761995079

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0402-2022

Related Recalls

(1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices: 3101704 TRAV RAIL CARR E-SYST STD 3102514 TR CARRIER SLIM/RAISED, LR 3101705 TRAV RAIL CARR ESYST WIDE 3102517 TR CARR. NORMAL/LOWER. LR 3102506 TR CARRIER WIDE/RAISED ML 3102519 TR CARR. LOW.LR 30MM/PAIR 3102511 TR CARRIER NORMAL, LR 3102531 TRAVERSE RL CARRIER STD/RAISED 3102512 TR CARRIER WIDE, LR 3102532 TRAVERSE RL CARRIER WD/RAISED 3102513 TR CARRIER SLIM, LR 3102562 TR CARRIER, PARALLEL/WIDE

Hill-Rom

Class I - Dangerous

Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate installation. There is potential that the screws are unable to secure the traverse rail appropriately and could loosen over time causing the rail system to fall, potentially causing injury to caregivers and/or patients

Jan 14, 2022 Other Medical Devices Nationwide View Details →