The FDA has posted 5 enforcement recalls of programmable diagnostic computer devices since 2025, including 1 Class I (most serious) recall. Most recent report: Sep 23, 2026.
Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.
Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal printer…
Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2.…
Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error message on the Merge Hemo Client ( Pressure…
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Computer, Diagnostic, Programmable”). Informational only — verify against the FDA before acting.