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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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