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Internal Battery PM Upgrade USB Drive PRT-01907-000

by Ventec Life Systems, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

5 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850018761451 UDI-DI Date2 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

5 recalls · 5 ongoing · FDA

    • Ongoing Z-2525-2026 FDA Class II initiated 8 May 2026

    Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.

    • Ongoing Z-1942-2026 FDA Class I initiated 25 Mar 2026

    Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk

    • Ongoing Z-1196-2025 FDA Class I initiated 3 Feb 2025

    Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.

    • Ongoing Z-1070-2024 FDA Class I initiated 9 Jan 2024

    The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Detachment of the spiral wrap can compromise structural integrity, functionality and/ or performance resulting in occlusions or leaks of the breathing circuit which may cause serious injury or death. The risk of injury or death is increased for ventilator dependent patients.

    • Ongoing Z-1902-2021 FDA Class II initiated 10 May 2021

    Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. The shutdown potentially prevents the ventilator from providing ventilation therapy.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Internal Battery PM Upgrade USB Drive
Generic Name
Software upgrade/unlocking key
Model / Ref / Catalog
PRT-01907-000
Primary DI / UDI-DI
00850018761451
510(k) Number
FDA Product Code
CBK, NOU, CAW, NHJ
GMDN Term
Software upgrade/unlocking key
Device Class
Class II
Regulation Number
868.5895, 868.5440, 868.5905
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K162877)

Show all (12)

Other devices from Ventec Life Systems, Inc.

See all devices from Ventec Life Systems, Inc. →

Properties

  • Lot / Batch Number
  • Manufacturing Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No