ONE-CUFRecalls & reported problems across all models
GE Medical Systems Information Technologies, Inc. · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one ONE-CUF model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 12 models of ONE-CUF by GE Medical Systems Information Technologies, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, 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 at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
ONE-CUF recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 12 of these models · Recall details · FDA record ↗
Most reported ONE-CUF problems
Device problems
- Low Readings1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
ONE-CUF models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ONE-CUF ONE-A2-2ABlood Pressure Cuff1 recall1 report
- ONE-CUF ONE-A1-1BBlood Pressure Cuff1 recall0 reports
- ONE-CUF ONE-P1-1BBlood Pressure Cuff1 recall0 reports
- ONE-CUF ONE-A2-2A-LBlood Pressure Cuff1 recall0 reports
- ONE-CUF ONE-P2-1BBlood Pressure Cuff1 recall0 reports
- ONE-CUF ONE-A1-2ABlood Pressure Cuff1 recall0 reports
- ONE-CUF ONE-P1-2ABlood Pressure Cuff1 recall0 reports
- ONE-CUF ONE-A2-1BBlood Pressure Cuff1 recall0 reports
- ONE-CUF ONE-P2-2ABlood Pressure Cuff1 recall0 reports
- ONE-CUF ONE-A2-1B-LBlood Pressure Cuff1 recall0 reports
- ONE-CUF ONE-A3-2ABlood Pressure Cuff1 recall0 reports
- ONE-CUF ONE-A3-1BBlood Pressure Cuff1 recall0 reports
Recent ONE-CUF adverse event reports
The 1 most recent reports across all models, 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 GE Medical Systems Information Technologies, Inc. products
All GE Medical Systems Information Technologies, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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