Transonic HQF3FD

• FDA 510(k) K872048 decided 21 Jun 1988 Active
• FDA GUDID UDI-DI 00877466003988 listed 8 Oct 2020 Listed

• 10 recalls, same reason

  • Terminated Z-2724-2015 FDA Class II ·initiated 27 Jul 2015
  • Terminated Z-2727-2015 FDA Class II ·initiated 27 Jul 2015
  • Terminated Z-2723-2015 FDA Class II ·initiated 27 Jul 2015
  • Terminated Z-2720-2015 FDA Class II ·initiated 27 Jul 2015
  • Terminated Z-2725-2015 FDA Class II ·initiated 27 Jul 2015
  • Terminated Z-2729-2015 FDA Class II ·initiated 27 Jul 2015
  • Terminated Z-2722-2015 FDA Class II ·initiated 27 Jul 2015
  • Terminated Z-2726-2015 FDA Class II ·initiated 27 Jul 2015
  • Terminated Z-2721-2015 FDA Class II ·initiated 27 Jul 2015
  • Terminated Z-2728-2015 FDA Class II ·initiated 27 Jul 2015

  Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number.

1. 27 Jul 2015 Recall initiated FDA recalls Z-2727-2015
2. 27 Jul 2015 Recall initiated FDA recalls Z-2723-2015
3. 27 Jul 2015 Recall initiated FDA recalls Z-2720-2015
4. 27 Jul 2015 Recall initiated FDA recalls Z-2725-2015
5. 27 Jul 2015 Recall initiated FDA recalls Z-2729-2015
6. 27 Jul 2015 Recall initiated FDA recalls Z-2722-2015
7. 27 Jul 2015 Recall initiated FDA recalls Z-2726-2015
8. 27 Jul 2015 Recall initiated FDA recalls Z-2721-2015
9. 27 Jul 2015 Recall initiated FDA recalls Z-2728-2015
10. 8 Oct 2020 Listed FDA GUDID 00877466003988

2 earlier events are in the sections above.

Trade name

Transonic

Generic name

Invasive vascular ultrasound system

Model / reference

HQF3FD

Primary DI / UDI-DI

00877466003988

510(k) Number

K872048 ↗

FDA product code

DPW

GMDN term

Invasive vascular ultrasound system

Device class

Class II

Regulation number

870.2100

GUDID distribution status

In Commercial Distribution

Category: Invasive vascular ultrasound system

Other devices filed under FDA product code DPW (Flowmeter, Blood, Cardiovascular).

• PeriCam PSI NR by Perimed, Inc.
• CLINIFLOW II, #701, ELECTROMAGN. BLD. SY by Carolina Medical Electronics
• CAPIOX CARDIOTOMY RESERVOIR by Terumo Cardiovascular Systems Corporation
• CARDIOQ, MODEL 9051-7005 by Deltex Medical
• MODIFIED FLOCATH PULMONARY ARTERY CATHETER by Cardio Metrics, Inc.
• VTI 20 MHZ Disposable Doppler Probe, Straight, Box 108200 by VASCULAR TECHNOLOGY, INCORPORATED
• 07-150-20 Mizuho 20 MHz Surgical Doppler Transceiver, AC 128160-AC by VASCULAR TECHNOLOGY, INCORPORATED
• MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 by Arrow Intl., Inc.
• MODIFIED CONTINUOUS CARDIAC OUTPUT MONITOR SYSTEM by Cardio Metrics, Inc.
• BACH-SIMPSON MODEL BVM30 by Bach-Simpson, Ltd.

• Transonic HQC1.5FMC

  Class II

  FDA 510(k) K872048 Active Cleared 21 Jun 1988 GUDID on market

• Transonic HQC4FMV

  Class II

  FDA 510(k) K872048 Active Cleared 21 Jun 1988 GUDID on market

• Transonic HQC3FMC

  Class II

  FDA 510(k) K872048 Active Cleared 21 Jun 1988 GUDID on market

• Transonic HQC2MP

  Class II

  FDA 510(k) K872048 Active Cleared 21 Jun 1988 GUDID on market

See all devices from Transonic Systems Inc. →