Ge Healthcare Nuclear Testing Recall

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GE HealthCare Recalls Nuclear Medicine Systems for Detector Fal…

(1 days ago) People also askDoes GE Healthcare have a nuclear medicine recall?GE HealthCare is recalling some of its nuclear medicine imaging systems amid concerns they could cause serious injury or death. The U.S. Food and Drug Administration alerted patients and providers about the issue Wednesday afternoon, labeling it as the agency’s “most serious” type of recall.GE HealthCare recalling nuclear imaging systems as FDA warns of radiologybusiness.comWhy is GE Healthcare recalled?The FDA labeled the recall of the GE HealthCare (Nasdaq:GEHC) Nuclear Medicine 600/800 Series systems as Class I, the most serious kind. GE HealthCare recalled the imaging platforms after identifying an issue with two mechanisms. These mechanisms prevent uncontrolled detector movement.GE HealthCare recalls scanner for patient crushing riskmassdevice.comWhy did GE issue a safety notice on its nuclear medicine systems?GE Healthcare (NYSE: GE ) issued an urgent field safety notice on its nuclear medicine systems after part of an Infinia Hawkeye 4 system collapsed and killed a patient in a New York Veterans Administration hospital. Last month a 66-year-old patient was crushed by the Infinia system, a gamma camera, while undergoing a procedure.GE Healthcare takes nuclear imaging systems off line after unit massdevice.comShould GE Healthcare stop using nuclear medicine?On Dec. 18, GE HealthCare sent an urgent medical device correction letter to its customers and recommended that they stop using the Nuclear Medicine systems until GE HealthCare’s service technicians complete an inspection.FDA updates recall on GE Healthcare imaging device - The Business Jou…bizjournals.comFeedbackFood and Drug Administration (.gov)https://www.fda.gov/medical-devices/medical-deviceGE HealthCare Recalls Nuclear Medicine Systems for …GE HealthCare is recalling the Nuclear Medicine 600 and 800 Series systems after identifying an issue with two mechanisms that prevent uncontrolled detector movement. First, there is a risk that the ball screw that serves as design mitigation for the suspended mass of the detector may fail. Additionally, some … See more

https://www.fda.gov/medical-devices/medical-device-recalls/ge-healthcare-recalls-nuclear-medicine-600800-series-systems-risk-detector-fall-may-injure-patients#:~:text=GE%20HealthCare%20is%20recalling%20the%20Nuclear%20Medicine%20600,the%20suspended%20mass%20of%20the%20detector%20may%20fail.

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GE’s nuclear imaging device can crush patients, FDA says, as Class I

(Just Now) WEBDive Brief: A fault that could cause a 1,212-pound detector in the imaging device to fall and crush the patient has triggered a Class I recall by GE HealthCare. …

https://www.medtechdive.com/news/GEHC-recall-nuclear-imaging-crush-death/643024/

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GE HealthCare recalling nuclear imaging systems as FDA warns of

(8 days ago) WEBGE HealthCare is recalling some of its nuclear medicine imaging systems amid concerns they could cause serious injury or death. The U.S. Food and Drug …

https://radiologybusiness.com/topics/medical-imaging/nuclear-medicine/ge-healthcare-recall-nuclear-imaging-systems-fda

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FDA Deems GE Nuclear Medicine Recall Class I FDAnews

(4 days ago) WEBThe FDA has deemed GE HealthCare’s recall of its Nuclear Medicine 600 and 800 Series systems as Class I, the most serious type of recall, as use of the …

https://www.fdanews.com/articles/211206-fda-deems-ge-nuclear-medicine-recall-class-i

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Class 1 Device Recall GE - Food and Drug Administration

(4 days ago) WEBGE HealthCare Service 800-4371171 Manufacturer Reason for Recall: A mitigation may not be correctly implemented. If this is the case, the detector can fall, …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=197812

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GE HealthCare Recalls Nuclear Medicine 600/800 Series …

(4 days ago) WEBReason for Recall. GE HealthCare is recalling the Nuclear Medicine 600 and 800 Series systems after identifying an issue with two mechanisms that prevent …

https://www.itnonline.com/content/ge-healthcare-recalls-nuclear-medicine-600800-series-systems-risk-detector-fall-may-injure

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Class 1 Device Recall GE - accessdata.fda.gov

(4 days ago) WEBA GE Healthcare representative will contact you to arrange for this correction. . If you have any questions or concerns regarding this notification, please …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=197814

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GE HealthCare recalls half-ton scanners that may crush patients

(4 days ago) WEBBy Andrea Park Feb 16, 2023 10:12am. GE Healthcare Class I recall Imaging FDA. GE HealthCare has begun a recall of several models of its nuclear medicine imaging …

https://www.fiercebiotech.com/medtech/ge-healthcare-lands-class-i-recall-1200-pound-scanners-risk-falling-patients

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FDA updates recall on GE Healthcare's Nuclear Medicine …

(6 days ago) WEBThe Food and Drug Administration reported a Class I recall, the most serious type, for the Nuclear Medicine 600/800 Series systems. The device is used to …

https://www.bizjournals.com/boston/news/2023/02/24/fda-updates-recall-on-ge-healthcare-imaging-device.html

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FDA: GE Healthcare Recalls Nuclear Medicine Systems Due to

(1 days ago) WEBCompany technicians are working to fix two issues that could lead to patients being crushed or trapped beneath the 1,200-lb device. By L.A. McKeown. …

https://www.tctmd.com/news/fda-ge-healthcare-recalls-nuclear-medicine-systems-due-patient-injury-risk

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GE HealthCare's Recall of Nuclear Medicine 600/800 Series …

(8 days ago) WEBGE HealthCare recalled the Nuclear Medicine 600/800 Series systems after identifying a problem with two mechanisms that prevent uncontrolled detector …

https://www.mpo-mag.com/contents/view_breaking-news/2023-02-16/ge-healthcares-recall-of-nuclear-medicine-600800-series-systems-is-class-i/

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GE HealthCare issues Class I recall of Nuclear Medicine 600/800 …

(6 days ago) WEBThe FDA reported the most serious type of recall for an imaging device made by GE HealthCare because "the 1,212-pound detector could fall, potentially …

https://www.bizjournals.com/boston/news/2023/02/16/ge-healthcare-issues-class-i-recall-of-hospital-im.html

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FDA classifies recall of certain GE HealthCare Nuclear Medicine …

(5 days ago) WEBThe FDA said GE HealthCare is recalling the Nuclear Medicine 600 and 800 Series systems after identifying an issue with two mechanisms that prevent …

https://seekingalpha.com/news/3937588-fda-classifies-recall-of-certain-ge-healthcare-nuclear-medicine-systems-as-most-serious

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Death Spurs GE to Recall Scanning System MedPage Today

(Just Now) WEBThe FDA announced on Monday a class I recall of GE Healthcare's nuclear medicine systems stemming from a patient death reported last month. On June 5, the …

https://www.medpagetoday.com/radiology/nuclearmedicine/40746

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GE Healthcare recalls nuclear medicine imaging systems

(5 days ago) WEBGE Healthcare is recalling 996 of the machines in the United States manufactured between Jan. 1, 1997, and July 1, 2012, and distributed until Sept. 1, …

https://www.medtechdive.com/news/ge-healthcare-recalls-nuclear-medicine-imaging-systems/542462/

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GE HealthCare recalls body scanners over risk of trapping, crushing

(Just Now) WEBGE HealthCare issued a recall of 688 of its Nuclear Medicine 600/800 Series Systems after identifying an issue that could lead to the machine's detector falling and trapping or …

https://www.beckershospitalreview.com/supply-chain/ge-recalls-body-scanners-over-risk-of-trapping-crushing-patients.html

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GE Recalls Over 20 Scanner Models after Patient Crushed to Death

(9 days ago) WEBFollowing the death of a patient last month, GE Healthcare issued a recall for several of its nuclear imaging scanners. FDA regulators issued Class I recall status …

https://www.mddionline.com/testing/ge-recalls-over-20-scanner-models-after-patient-crushed-to-death

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GE recalls scanners after patient crushed to death

(6 days ago) WEBGE Healthcare is urging customers to stop using more than 20 models of its nuclear imaging devices until the company can inspect each one and ensure it's not …

https://www.fiercebiotech.com/medical-devices/ge-recalls-scanners-after-patient-crushed-to-death

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GE HealthCare Recalls Nuclear Medicine 600/800 Series Systems …

(5 days ago) WEBReason for Recall: GE HealthCare is recalling the Nuclear Medicine 600 and 800 Series systems after identifying an issue with two mechanisms that prevent uncontrolled …

https://www.csagroup.org/recall/ge-healthcare-recalls-nuclear-medicine-600-800-series-systems-for-risk-of-detector-fall-that-may-injure-patients/

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GE HealthCare Recalls Nuclear Medicine Systems 24x7

(7 days ago) WEBThe FDA has identified this as a class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. GE Nuclear Medicine …

https://24x7mag.com/standards/fda-updates/recalls/ge-healthcare-recalls-nuclear-medicine-systems/

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GE HealthCare recalls scanner for patient crushing risk - MassDevice

(3 days ago) WEBThe recall includes the NM 830 and 830 ES as well as the NM/CT 850, 850 ES, 860, 860 ES, 870 CZT, 870 DR and 870 ES. GE Healthcare distributed the affected …

https://www.massdevice.com/ge-healthcare-recalls-scanner-for-patient-crushing-risk/

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Class 1 Recall: GE Healthcare Recalls Millennium Nuclear Medicine

(8 days ago) WEBClass 1 Recall: GE Healthcare Recalls Millennium Nuclear Medicine Systems Due to Risk of Detector Detaching and Falling The FDA has identified this as a …

https://www.medwrench.com/article/56304/class-1-recall-ge-healthcare-recalls-millennium-nuclear-medicine-systems-due-to-risk-of-detector-detaching-and-falling

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GE Healthcare takes nuclear imaging systems off line after unit

(5 days ago) WEBGE Healthcare (NYSE:GE) issued an urgent field safety notice on its nuclear medicine systems after part of an Infinia Hawkeye 4 system collapsed and killed a …

https://www.massdevice.com/ge-healthcare-takes-nuclear-imaging-systems-line-after-unit-collapses-and-kills-patient/

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Do Not Use Cue Health’s COVID-19 Tests

(3 days ago) WEBIf you have questions, email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100. The …

https://www.fda.gov/medical-devices/safety-communications/do-not-use-cue-healths-covid-19-tests-due-risk-false-results-fda-safety-communication

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