ONE-CUF ONE-A2-2ARecalls & reported problems
GE Medical Systems Information Technologies, Inc. · ONE-CUF, ADULT, DINACLICK 5 , 23 - 33 CM, SINGLE · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00195278571397), received between Mar 21, 2024 and Mar 21, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Low Readings” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Apr 9, 2024Open, Classified
Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.
Z-2027-2024 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Low Readings1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 21, 2024Low Readings; Manufacturing, Packaging or Shipping Problem; Low Readings; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT A PATIENT WAS UNNECESSARILY TREATED FOR INCORRECTLY LOW NIBP READINGS. THE PATIENT DID NOT SUSTAIN ANY INJURY DUE TO THE ALLEGED UNNECESSARY MEDICAL TREATMENT. THE GE HEALTHCARE ONE-CUF NIBP CUFF WAS CONNECTED TO A NON-GEHC (PHILIPS) PATIENT MONITOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18955558 ↗
Other Blood Pressure Cuff devices
- Medline MDS9380Medline Industries, Inc. · blood pressure cuff108 reports
- ONE-CUF ONE-P1-2AGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall0 reports
- ONE-CUF ONE-A1-1BGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall0 reports
- ONE-CUF ONE-P1-1BGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall0 reports
- ONE-CUF ONE-A2-2A-LGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall0 reports
- ONE-CUF ONE-A3-2AGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall0 reports
- Radius VSM 4826Masimo Corporation · blood pressure cuff1 recall0 reports
- ONE-CUF ONE-A3-1BGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.