Novarad Corporation

Complete recall history across all FDA and CPSC categories — 4 total recalls

Novarad Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (4)

FDA medical device enforcement actions by Novarad Corporation

Date Product Reason Class
Sep 10, 2019 NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication... The firm received a report of an atypical dataset being generated. When using... Class II
Aug 12, 2016 NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation... Novarad Corporation announces a voluntary field action for the NovaPACS versi... Class II
Nov 16, 2015 NovaPACS  Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novara... The SUV values that are being calculated in the PET/CT fusion tool are incorr... Class II
May 9, 2013 NovaPACS  versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by... Potential for images to be flipped while streaming, which could incorrectly d... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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