SCHILLER BP-200 plusRecalls & reported problems
Schiller AG · The BP-200 plus is intended to be used as an adjunct to exercise stress testing devices. It is intended to measure and display diastolic and systolic blood pressure, heart rate, percentage of oxygen saturationin arterial blood (SpO2) and pulse rate in adult or adolescent patients during stress tests. The BP-200 plus can be used for patients of both sexes and all races. · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613365000122), received between Oct 30, 2024 and Mar 21, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings2
- Unable to Obtain Readings2
- High Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2025Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THAT THE DEVICE FUNCTIONS NORMALLY DURING RESTING BLOOD PRESSURE MEASUREMENTS. HOWEVER, DURING STRESS TESTING, THE DEVICE FAILS TO DISPLAY BLOOD PRESSURE VALUES AFTER STAGE 2, AND OCCASIONALLY DURING STAGE 2 AS WELL. THE USER ALSO EXPERIENCED ERROR CODES 180, 181, AND 182, ALONG WITH OCCASIONAL ABNORMAL BLOOD PRESSURE READINGS DURING STRESS TESTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21661633 ↗MalfunctionMar 21, 2025Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THAT THE DEVICE FUNCTIONS NORMALLY DURING RESTING BLOOD PRESSURE MEASUREMENTS. HOWEVER, DURING STRESS TESTING, THE DEVICE FAILS TO DISPLAY BLOOD PRESSURE VALUES AFTER STAGE 2, AND OCCASIONALLY DURING STAGE 2 AS WELL. THE USER ALSO EXPERIENCED ERROR CODES 180, 181, AND 182, ALONG WITH OCCASIONAL ABNORMAL BLOOD PRESSURE READINGS DURING STRESS TESTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21661632 ↗MalfunctionOct 30, 2024High Readings; High Readings
DURING A STRESS TEST THE DEVICE SHOWED VERY HIGH BLOOD PRESSURE VALUES.
Patient problems: Insufficient Information
MAUDE report 20565839 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.