Product code ILQ

Reports per year

Source: FDA adverse event reports by year received, 2011–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Recent recalls

• 2026-08-14Open, ClassifiedDevice Design

  TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798

  Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure.

• 2026-08-14Open, ClassifiedDevice Design

  TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799

  Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure.

• 2023-04-18Open, ClassifiedDevice Design

  Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567

  Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.

• 2015-10-01TerminatedProcess control

  Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.

  Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging.

• 2015-07-06TerminatedSoftware design

  Philips GoSafe Communicator 7000L Personal emergency response system.

  Home communicator Model 7000L may not sense the phone line under certain unusual landline phone conditions.

• 2013-09-17TerminatedCounterfeit

  Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system also connects team members and departments from radiology, physical therapy, transport, environmental services and more. Responder 5 is used in hospitals and long term patient care facilities to allow for remote communications between patients and patient monitoring devices and healthcare providers

  A counterfeited electronic component was identified in the products affected. The component, a data transceiver (transmitter/receiver), is associated with the intercommunication of these devices in the Responder 5 system across the L-Net data path. Failure of a data transceiver results in the loss of nurse call functionality in the associated room, and may disrupt communications on the L-Net run

• 2013-02-01TerminatedNonconforming Material/Component

  P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii P10 Device. MyTobii P10 is a portable eye-controlled communication device featuring the Tobii Eye Control system.

  Tobii ATI customers P10 external battery pack, which contains sealed lead-acid batteries, malfunctioned while recharging and produced smoke with a chemical smell.

• 2011-06-29TerminatedEnvironmental control

  Tobii C-Series Lithium batteries Type TB8A, TB8B, TB12A used with the Tobii C8 and Tobii C12 Speech Generating Communication Devices. Communication device for the impaired and functions as a speech generating device; text or symbols can be used to generate synthesized or digitized speech. Perfect for asking or answering questions, having a conversation.

  Lithium Batteries may overheat and become combustible

• 2009-11-25TerminatedOther

  Philips Lifeline Personal Help Button Pendant Classic and Slimline Style.

  Pendant Personal Help Button neck cord may not break away and if not will present a potential choking risk.

• TerminatedUnder Investigation by firm

  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

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