System, Communication, Powered

Reports per year

Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 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.

• Open, ClassifiedUnder Investigation by firm

  Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for the SoundPOD Bluetooth Speaker accessory to the ProSlate Speech Generation Devices (including Proslate 13: B398PS130; Proslate 10: B398PS100; Proslate 8: B398PS080; Proslate 4: B398PS040)

  Warning Added: Using damaged cables or chargers, or charging when moisture is present, can cause fire, electric shock, injury, or damage to Speech Generating Device or other property

• TerminatedSoftware design

  NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.

  Firm discovered a firmware memory leak with a supplier-manufactured component.