NA GZ-130PRecalls & reported problems
Nihon Kohden Corporation · Vital Sign Telemeter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Nihon Kohden GZ telemeter is a wireless vital sign transmitter that sends a patient's monitoring signals to a central monitor. Its 191 reports are mostly malfunctions, describing output and communication problems such as lost connections, power problems, and missing alarms. Most reports describe no patient impact. There is 1 death report and no injuries. No recalls name this device. Reports rose from 29 in the year before to 54 in the latest year.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 203
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 203 adverse event reports that list this exact device (DI 04931921117415), received between Mar 29, 2018 and Sep 30, 2026 — classified as 1 death, 1 injury, 201 malfunctions.
The most frequently reported specific device problem is “Output Problem” (56 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Output Problem56
- Communication or Transmission Problem39
- Power Problem25
- Incorrect, Inadequate or Imprecise Result or Readings18
- Protective Measures Problem18
- Complete Loss of Power15
- Display or Visual Feedback Problem15
- No Audible Alarm15
Patient problems
- No Clinical Signs, Symptoms or Conditions199
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 203 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Unable to Obtain Readings; Sensing Intermittently
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950239 ↗MalfunctionSep 30, 2026False Alarm; Signal Artifact/Noise; Output Problem; Protective Measures Problem
The Biomedical Engineer (Biomed) reported that the GZ Transmitter displayed artifacts during setup when the ECG leads were connected. The device had also alarmed for asystole when no leads were connected. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947796 ↗MalfunctionSep 29, 2026Image Display Error/Artifact; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934452 ↗MalfunctionSep 25, 2026Unable to Obtain Readings; Communication or Transmission Problem
The Biomedical Engineer (Biomed) reported that the GZ Transmitter was in intermittent Comm Loss. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899918 ↗MalfunctionSep 23, 2026Unable to Obtain Readings; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874027 ↗InjurySep 14, 2026Communication or Transmission Problem; Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762920 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735084 ↗MalfunctionSep 11, 2026Power Problem; Intermittent Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732931 ↗MalfunctionSep 10, 2026Device Alarm System; Protective Measures Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715967 ↗MalfunctionSep 8, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50673372 ↗MalfunctionSep 3, 2026Unable to Obtain Readings; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50592878 ↗MalfunctionSep 3, 2026Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50591882 ↗MalfunctionAug 31, 2026Signal Artifact/Noise; Output Problem
The Biomedical Engineer (BME) reported that the GZ transmitter was experiencing a lot of artifacts when the case was touched near the ECG connection. Not in patient use, discovered during setup.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50524033 ↗MalfunctionAug 26, 2026Communication or Transmission Problem; Output Problem; Intermittent Communication Failure
The Biomedical Engineer (Biomed) reported that the GZ Transmitter was intermittently going into Comm Loss. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50457373 ↗MalfunctionAug 20, 2026Power Problem; Complete Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50354780 ↗MalfunctionAug 18, 2026Power Problem; Complete Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50308952 ↗MalfunctionAug 14, 2026Device Alarm System; Protective Measures Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50255054 ↗MalfunctionAug 13, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50237733 ↗MalfunctionAug 12, 2026Communication or Transmission Problem; Intermittent Communication Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50226202 ↗MalfunctionAug 11, 2026Unable to Obtain Readings; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50214529 ↗MalfunctionAug 3, 2026Communication or Transmission Problem; Power Problem; Complete Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50118597 ↗MalfunctionAug 3, 2026Application Program Problem; Unintended Application Program Shut Down
The Biomedical Engineer (BME) reported that the GZ Telemetry Transmitter is constantly rebooting and not staying on. The BME swapped out the batteries with a new set and the issue still persists. Not in patient use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50113076 ↗MalfunctionJul 29, 2026No Display/Image; Display or Visual Feedback Problem; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50068736 ↗MalfunctionJul 20, 2026Communication or Transmission Problem; Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25876550 ↗MalfunctionJul 17, 2026Power Problem; Complete Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25856925 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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