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FDA (Device enforcement)Recalled 2021-10-14closedclass ii

Hill-Rom Inc.: 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

Is my product affected?

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

  • UPC 00887761001541
  • UPC 00887761021198
  • UPC 00887761985209
  • UPC 00887761995079

Check against the official notice below — it lists the full affected range.

What happened

Hill-Rom Inc. is recalling 1,050 units of NaviCare and Voalte nurse call communication systems distributed worldwide and throughout the US. The affected products include NaviCare Nurse Call Part Numbers 3.6, 3.7, and 3.9, and Voalte Nurse Call Part Number 4.0, all running software versions 3.5.400 and above. An unrecoverable error may cause a component to fail during the reboot cycle, rendering the device non-functional and requiring replacement.

The recall record does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.

Details from the source

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. Distribution: Worldwide distribution - US Nationwide. Quantity: 1,050 units Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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