Home › PRENTKE ROMICH COMPANY › PRiO

PRiO

PRENTKE ROMICH COMPANY · Model PRiO · UDI-DI 00858526006576

ILQ Prescription

510(k) clearances

729

Adverse events (22 deaths)

Recalls

Facilities

Description

The PRiO is an iPad based communication tool featuring the iPad Air and the popular LAMP Words for Life (WFL) Vocabulary. LAMP WFL is a full vocabulary communication app that combines the power of UNITY with the principles and strategies of Language Acquisition through Motor Planning (LAMP). The WFL vocabulary is appropriate for individuals with a wide range of language and communication skills.

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.