MEDISTIM ASA
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
Devices registered here (1)
- Flowmeter, Blood, CardiovascularProduct code DPW (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2100
Recalls & enforcement
- Class IIOngoing2025-09-26Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules replaced.
- Class IITerminated2017-04-25A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.
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. “MEDISTIM ASA (FEI 3003647374) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003647374-medistim-asa/
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