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NuPoint

PRENTKE ROMICH COMPANY · Model NP · UDI-DI 00858526006606

ILQ Prescription

510(k) clearances

729

Adverse events (22 deaths)

Recalls

Facilities

Description

NuPoint is an effective access solution for users who have limited or no use of their hands. Using optical sensors, NuPoint tracks a small reflective dot on the user’s forehead, glasses or other convenient spot converting the natural movement of the user’s head to accurately control the pointer on the screen. Key activations are made by dwelling over the desired key. Additional movement settings, like vertical and horizontal controls help customize control of the pointer to optimize the user’s accuracy and ease of use. NuPoint is designed specifically to work with the Accent 1400, Accent 1000* and Accent 800**. NuPoint plugs directly into the device requiring no additional power or cables.

Recalls

Date	Firm	Reason
2026-07-08	Tobii Dynavox Llc	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.
2026-07-08	Tobii Dynavox Llc	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.
2023-02-24	Tobii Dynavox Llc	Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.
2022-05-31	Baxter Healthcare Corporation	An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call, software version
2022-04-13	Baxter Healthcare Corporation	Firm discovered a firmware memory leak with a supplier-manufactured component.
2022-04-13	Baxter Healthcare Corporation	Firm discovered a firmware memory leak with a supplier-manufactured component.
2022-03-28	Medminder Systems, Inc.	Discontinuation of the Emergency Alert watch or pendant will no longer connect to the emergency alert system for all models. Older Model (legacy) without screen medical alert feat
2021-10-14	Hill-Rom Inc.	An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.
2021-10-11	Forbes Rehab Services Inc	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 proper
2017-12-14	Dynavox Systems Llc	The battery is integral to the device. If the device sits unused and is not charged for a lengthy period of time (a few months) the battery will go into a deep discharge state and

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.