Recall archive
9 recalls · page 1 of 1
Reported Nov 15, 2023
The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carestream Health, Inc.
Matched: Brand · Reason for recall — There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution…
FDA (openFDA device enforcement)
Reported Aug 13, 2014
KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carestream Health Inc.
Matched: Brand — A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 12, 2014
Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carestream Health Inc.
Matched: Brand · Product · Product details · Reason for recall — Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2014
Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carestream Health Inc.
Matched: Brand · Product · Product details · Reason for recall — Carestream received a report of an exposure being initiated without a patient image captured. The patient was imaged 2 times before an image was…
FDA (openFDA device enforcement)
Reported Jan 29, 2014
DRX-Evolution with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carestream Health, Inc.
Matched: Brand · Reason for recall — Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 15, 2014
Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carestream Health Inc.
Matched: Brand · Product · Product details · Reason for recall — It was discovered that Carestream received a report from a customer that 2 different patients were re-exposed due to the fact that the processed…
FDA (openFDA device enforcement)
Reported Nov 20, 2013
Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP The CARESTREAM PACS is an image management system whose…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carestream Health Inc.
Matched: Brand · Product · Product details · Reason for recall — Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from…
49 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 13, 2013
DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carestream Health Inc.
Matched: Brand · Reason for recall — Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 21, 2013
Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carestream Health Inc.
Matched: Brand · Product · Product details — Due to potential for an x-ray exposure technique change.
FDA (openFDA device enforcement)
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