RegWardenFDA facility compliance records
Facility

TRANSONIC SYSTEMS, INC.

4 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2013: 1 recalls; 2015: 2 recalls; 2017: 1 inspections; 2018: 1 recalls, 1 inspections1’13’142’15’161’172’18’19’20’21’22’23’24’25’26
  • Recalls (4)
  • Inspections (2)

Devices registered here (1)

  • Computer, Diagnostic, Pre-Programmed, Single-Function
    Product code DXG (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1435

Recalls & enforcement

  • Class IITerminated2018-02-15
    The sterility of the device cannot be assured. There is a potential for an increased risk of infection.
  • Class IITerminated2015-07-27
    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.
  • Class IITerminated2015-02-17
    Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during dialysis procedures. The user saw a zero or a very low flow value displayed on HD03 and/or no measurements produced in other modes (recirculation; access flow; or cardiac …
  • Class IITerminated2013-03-28
    Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.

FDA inspections (2)

  • NAI2018-02-01
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • NAI2017-06-16
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “TRANSONIC SYSTEMS, INC. (FEI 1319030) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1319030-transonic-systems-inc/

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