Skip to content

General Purpose Sensor H4911NG

by Civco Medical Instruments Co., Inc.

General Purpose Sensor H4911NG is a Class II device made by Civco Medical Instruments Co., Inc., cleared under FDA 510(k) K092619 on 13 Nov 2009 and listed in FDA GUDID since 22 Aug 2017 (UDI-DI 00841436109390), active as of 23 Oct 2026. 17 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

8 ongoing

This device is named in the recall

Documents

510(k) K092619

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841436109390 UDI-DI Date22 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK092619 Date13 Nov 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K092619 decided 13 Nov 2009 Active
  • FDA GUDID UDI-DI 00841436109390 listed 22 Aug 2017 Listed

Recalls

17 recalls · 8 ongoing · FDA

  • 8 recalls, same reason

    • Ongoing Z-1738-2026 FDA Class II initiated 2 Mar 2026
    • Ongoing Z-1736-2026 FDA Class II initiated 2 Mar 2026
    • Ongoing Z-1735-2026 FDA Class II initiated 2 Mar 2026
    • Ongoing Z-1737-2026 FDA Class II initiated 2 Mar 2026
    • Ongoing Z-1732-2026 FDA Class II initiated 2 Mar 2026
    • Ongoing Z-1731-2026 FDA Class II initiated 2 Mar 2026
    • Ongoing Z-1734-2026 FDA Class II initiated 2 Mar 2026
    • Ongoing Z-1733-2026 FDA Class II initiated 2 Mar 2026

    There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

  • 4 recalls, same reason

    • Terminated Z-0396-2022 FDA Class II initiated 8 Oct 2021
    • Terminated Z-0397-2022 FDA Class II initiated 8 Oct 2021
    • Terminated Z-0398-2022 FDA Class II initiated 8 Oct 2021
    • Terminated Z-0395-2022 FDA Class II initiated 8 Oct 2021

    There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

  • 5 recalls, same reason

    • Terminated Z-1955-2012 FDA Class II initiated 7 May 2012
    • Terminated Z-1952-2012 FDA Class II initiated 7 May 2012
    • Terminated Z-1953-2012 FDA Class II initiated 7 May 2012
    • Terminated Z-1954-2012 FDA Class II initiated 7 May 2012
    • Terminated Z-1956-2012 FDA Class II initiated 7 May 2012

    The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.

Timeline

19 dated events

  1. Recall initiated FDA recalls Z-0398-2022
  2. Recall initiated FDA recalls Z-0395-2022
  3. Recall initiated FDA recalls Z-1738-2026
  4. Recall initiated FDA recalls Z-1736-2026
  5. Recall initiated FDA recalls Z-1735-2026
  6. Recall initiated FDA recalls Z-1737-2026
  7. Recall initiated FDA recalls Z-1732-2026
  8. Recall initiated FDA recalls Z-1731-2026
  9. Recall initiated FDA recalls Z-1734-2026
  10. Recall initiated FDA recalls Z-1733-2026

9 earlier events are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
General Purpose Sensor
Generic name
Patient positioning sensor
Model / Ref / Catalog
H4911NG
Primary DI / UDI-DI
00841436109390
510(k) Number
FDA product code
IYO
GMDN term
Patient positioning sensor
Device class
Class II
Regulation number
892.1560
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Length — 1.95 Inch
Width — 7 Inch

Related devices

Category: Patient positioning sensor

Cleared under the same submission (K092619)

and 8 more cleared under K092619

Similar devices in this category

Other devices filed under Patient positioning sensor.

Other devices from Civco Medical Instruments Co., Inc.

See all devices from Civco Medical Instruments Co., Inc. →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)