Carestream Health Inc
Complete recall history across all FDA and CPSC categories — 8 total recalls
Carestream Health Inc 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 (8)
FDA medical device enforcement actions by Carestream Health Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| May 25, 2017 | DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all othe... | Carestream found a single unit where four screws in the assembly were not app... | Class II |
| Jan 12, 2017 | Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019... | The firm received a complaint alleging that a DRX Revolution System could not... | Class II |
| Nov 21, 2016 | Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738... | Software error; Carestream Health Inc, received a complaint stating that when... | Class II |
| Jul 8, 2016 | Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE... | A software issue related to the generic volume measurement functionality coul... | Class II |
| Apr 15, 2016 | CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490... | Carestream Health received a complaint related to CARESTREAM Image Suite 4 fr... | Class II |
| Apr 15, 2016 | CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1... | Carestream Health received a complaint related to CARESTREAM Image Suite 4 fr... | Class II |
| Aug 7, 2015 | CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a per... | Software defect that impacts image alignment when using the automatic stitchi... | Class II |
| Nov 25, 2014 | DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog ... | While servicing a unit at a customer site, a field engineer discovered a brok... | 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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