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The Medical Device Business Journal — Medical Device News & Articles | MassDevice

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Spacelabs Healthcare

Some SpaceLabs devices vulnerable to serious cyberattack

February 19, 2020 By Nancy Crotti

Certain SpaceLabs Healthcare telemetry receivers are at risk of cyberattack by a program as virulent as the WannaCry malware attacks of 2017, according to the U.S. Department of Homeland Security. The SpaceLabs Xhibit telemetry receiver model number 96280, v1.0.2 and all versions of a former SpaceLabs product, Arkon, may be affected by the BlueKeep virus, […]

Filed Under: Business/Financial News, Featured, Health Technology Tagged With: Cybersecurity, Microsoft, Spacelabs Healthcare, U.S. Department of Homeland Security

HRS 2019 Roundup: Medtronic touts extravascular ICD pilot

May 13, 2019 By Brad Perriello

The pilot study of an extravascular implantable cardiac defibrillator developed by Medtronic (NYSE:MDT), which is designed to deliver both defibrillation and anti-tachycardia pacing using leads placed outside the heart and venous system, showed strong safety and efficacy results. The safety outcome for the 26-patient study, presented last week at the annual meeting of the Heart […]

Filed Under: Cardiovascular, Clinical Trials, Featured Tagged With: AFTx, Biosense Webster, Boston Scientific, Cardiac Rhythm Management, Cardiofocus, HRS 2019, Javelin Medical, Johnson and Johnson, MediLynx, Medtronic, Preventice, Spacelabs Healthcare

Spacelabs, OrthoScan win DoD contracts

December 17, 2018 By Fink Densford

Spacelabs Healthcare and OrthoScan have won contracts worth $450 million and $125 million, respectively, from the U.S. Department of Defense to supply it with medical-related equipment and services, according to a recently posted DoD press release. Snoqualmie, Wash.-based SpaceLabs won its $450 million firm-fixed-price, indefinite-delivery/indefinite/quantity contract to supply the defense agency with patient monitoring systems, […]

Filed Under: Business/Financial News, Featured, Imaging, Patient Monitoring Tagged With: orthoscan, Spacelabs Healthcare

SpaceLabs’ Arkon anesthesia system recalled again

August 13, 2018 By Nancy Crotti

The FDA  has slapped SpaceLabs Healthcare with a Class 1 recall of its Arkon anesthesia delivery system for going into a “failed state” on numerous occasions since 2013. The recall covers 253 units. No injuries or deaths were reported. During the failed state, the mechanical ventilation function stops working while the machine is in use […]

Filed Under: Food & Drug Administration (FDA), Recalls Tagged With: FDA, Spacelabs Healthcare

Endo Health warned by FDA on AMS pelvic mesh plant | Medtech regulatory news for the week of Apr. 21, 2014

April 22, 2014 By MassDevice Contributors Network Leave a Comment

FDA warns Endo Health on AMS pelvic mesh plant

April 17, 2014 by Brad Perriello

FDA warns Endo Health on pelvic mesh plant

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: American Medical Systems Holdings Inc., Emergo Group, Endo Health, Health Canada, Philips, Spacelabs Healthcare

Another recall for Spacelabs Healthcare’s Arkon anesthesia system

April 18, 2014 By Brad Perriello Leave a Comment

Another recall for Spacelabs Healthcare's Arkon anesthesia system

The FDA slapped Spacelabs Healthcare with a Class I recall after the medical device company pulled 16 of is Arkon anesthesia delivery devices due to a software bug.

The recall, of the Arkon device equipped with version 2.0 software, involves devices sold to hospitals in North Carolina and South Carolina, according to the FDA. The Class I recall status denotes a problem that could cause serious injury or death.

Filed Under: Food & Drug Administration (FDA), News Well, Recalls, Regulatory/Compliance Tagged With: Anesthesia, Spacelabs Healthcare

Recall: Spacelabs Healthcare pulls anesthesia workstations over excess CO2 risk

March 27, 2013 By Arezu Sarvestani Leave a Comment

Spacelabs Medical logo

Washington-based Spacelabs Healthcare recalled a slate of its Spacelabs BleaseSirius and BleaseFocus anesthesia workstations as well as certain absorbers contained in service kits over concerns that they may contain a defect which could result in excess carbon dioxide in the gas delivered to a patient.

Filed Under: News Well, Recalls, Respiratory Tagged With: Anesthesia, Spacelabs Healthcare

More warnings on metal-on-metal hip implants in U.K, New Zealand | Regulatory Roundup

April 16, 2012 By MassDevice staff Leave a Comment

hip x-ray

Filed Under: 510(k), Implants, News Well, Orthopedics, Recalls Tagged With: Chromogenex, Custom Spine, depuysynthes, Hips, ITGI Medical Ltd., Spacelabs Healthcare, Stryker

GPOs: Novation and Premier tout new deals

October 18, 2011 By MassDevice staff Leave a Comment

Novation
Premier

Hospital group purchasing organizations Novation and Premier signed new contracts this week, covering patient monitoring solutions, intra-aortic balloon catheters and pumps.

Novation awarded a three-year contract to Spacelabs Healthcare, a subsidiary of OSI Systems Inc. (NSDQ:OSIS), for patient monitoring and connectivity solutions.

Filed Under: Catheters, News Well, Patient Monitoring Tagged With: Arrow International, Deals Roundup, Novation, OSI Systems Inc., Premier Inc., Spacelabs Healthcare, Teleflex

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