Carestream Health, Inc.
Complete recall history across all FDA and CPSC categories — 17 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 (17)
FDA medical device enforcement actions by Carestream Health, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 2, 2023 | The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system ut... | There is a potential for unexpected failure of the electrical components with... | Class II |
| Oct 2, 2023 | DRX Revolution Mobile X-Ray System | Unexpected failure of electrical components within the CPI generator. | Class II |
| Jan 30, 2023 | DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For ... | After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Di... | Class II |
| Jan 6, 2020 | Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diag... | Carestream Health has discovered a potential safety problem that can lead to ... | Class II |
| Mar 19, 2019 | OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbe... | When the user performs the re-assignment of a parent / companion pair, the pa... | Class II |
| Jan 8, 2015 | CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete ... | Units device head descended unexpectedly | Class II |
| Jan 8, 2015 | CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to pro... | Units device head descended unexpectedly | Class II |
| Oct 30, 2014 | CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images th... | Reduced mammographic image quality when attempting to print true size multi-... | Class II |
| Jul 9, 2014 | Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7... | An on-site evaluation of the equipment parts that attach the Beta Assembly (x... | Class II |
| Dec 26, 2013 | KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by... | Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing V... | Class II |
| Nov 25, 2013 | DRX-Evolution with FF WS These products are permanently installed diagnost... | Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (... | Class II |
| Nov 25, 2013 | DRX-Evolution with CSH WS These products are permanently installed diagnos... | Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (... | Class II |
| Nov 25, 2013 | DR 7500 with FF WS These products are permanently installed diagnostic x-r... | Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (... | Class II |
| Jul 26, 2013 | DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY... | During an audit, Carestream discovered a DRX-1 System that captured an image ... | Class II |
| Jun 6, 2013 | Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images. | Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mo... | Class II |
| Jan 17, 2013 | KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Mod... | Missing symbols and manufacturing information on the clear carton label. The... | Class III |
| Jun 12, 2012 | Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc... | Carestream DRX-1 System batteries manufactured before June 2012 due to two oc... | 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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