MIDMARK CORPORATION
4 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (4)
- Inspections (2)
Devices registered here (1)
- Chair, Examination And TreatmentProduct code FRK (opens in a new tab) · Class I · General Hospital · 21 CFR 880.6140
Recalls & enforcement
- Class IIOngoing2026-08-21A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
- Class IIOngoing2026-07-20A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
- Class IITerminated2014-09-04Failure of the primary collimator may result in unintentional movement of the device. The unintentional movement will not result in the generation of an error message.
- Class IITerminated2013-09-20An error was identified in the Real Time Controller (RTC) firmware versions 3.0, 3.1, 3.2, and 3.3 used in Vantage Panoramic X-Ray systems. The error may cause the column of the Vantage Panoramic X-Ray unit to continue moving vertically despite the release of the movement control…
FDA inspections (2)
- VAI2018-04-02Voluntary Action Indicated · Postmarket Assurance: Devices · citations posted
- NAI2016-12-09No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
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. “MIDMARK CORPORATION (FEI 1523530) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1523530-midmark-corporation/
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