Transonic HQD3FMV

• FDA 510(k) K872048 decided 21 Jun 1988 Active
• FDA GUDID UDI-DI 00877466002141 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 00877466002141

2 earlier events are in the sections above.

Trade name

Transonic

Generic name

Surgical anti-adhesion material, implantable, non-bioabsorbable

Model / reference

HQD3FMV

Primary DI / UDI-DI

00877466002141

510(k) Number

K872048 ↗

FDA product code

DPW

GMDN term

Surgical anti-adhesion material, implantable, non-bioabsorbable

Device class

Class II

Regulation number

870.2100

GUDID distribution status

In Commercial Distribution

Category: Surgical anti-adhesion material, implantable, non-bioabsorbable

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

• VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES by Sonicaid, Inc.
• SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes by Huntleigh Healthcare, Ltd.
• SENSILASE PAD-IQ by Vasamed, Inc.
• VELCOM-100 by Waters Instruments, Inc.
• VTI 20 MHz Disposable Doppler Probe Grasp Capable Grip, Box 108380 by VASCULAR TECHNOLOGY, INCORPORATED
• AVALON GENERAL PURPOSE SCANNER, PREVIEW GP by Avalon Technology Corp.
• LASERFLO BLOOD PERFUSION MONITOR, MODEL BPM2 by Tsi, Inc.
• HIGH FREQUENCY LINEAR ARRAY (HFLA) SCANHEAD by Advanced Technology Laboratories, Inc.
• NIHON KOHDEN BLOOD FLOWMETERS #MFV-1100 by NIHON KOHDEN AMERICA, INC.
• FlowMet by Laser Associated Sciences, Inc.

• 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. →