Medical Device Alerts (MDAs) were introduced on 1 January 2003, to replace the previous types of safety warnings (Hazard notice, Safety notice, Device alert, Advice notice and Pacemaker technical note) which can be found under Publications > Safety warnings.
MDAs are distributed to the NHS in England via the Department of Health's Central Alerting System (CAS). MDAs remain valid unless they are updated or withdrawn. They are reviewed once they are five years old (and subsequently every year) and the lists on this website are amended accordingly.
Latest Medical Device Alerts
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17 Jun 2013 | Medical Device Alert: Laboratory test kit manufactured by Orgentec Diagnostika GmbH, distributed in the UK by Launch Diagnostics (MDA/2013/040)
This Medical Device Alert has been issued as there is a possibility of false positive results in tests for the diagnosis of lupus when using laboratory test kits manufactured by Orgentec Diagnostika GmbH.
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13 Jun 2013 | Medical Device Alert: Workstation software for computed tomography systems: Vitrea CT Brain Perfusion 2D application manufactured by Vital Images, Inc. (MDA/2013/039)
This Medical Device Alert has been issued as there is the risk of patient misdiagnosis, inappropriate treatment or treatment delay due to incompatibility of software with certain protocols or CT units.
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12 Jun 2013 | Medical Device Alert: Rusch Belly Bag urine collection bag with hip belt manufactured by Teleflex Medical (MDA/2013/038)
This Medical Device Alert has been issued as there is a risk to sterility due to compromised packaging.
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03 Jun 2013 | Medical Device Alert: SERVO-i ventilator system battery modules manufactured by Maquet (MDA/2013/037)
This Medical Device Alert has been issued due to the risk of early or unexpected loss of ventilation due to certain battery modules having a shorter than specified run time.
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31 May 2013 | Medical Device Alert: External pacemaker: MICRO-PACE REF 4580 manufactured by Pace Medical and distributed in the UK by APC Cardiovascular (MDA/2013/036)
This Medical Device Alert has been issued as an update to MDA/2013/001 and MDA/2012/070 on the return to market of external pacemaker MICRO-PACE REF 4580.
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17 May 2013 | Medical Device Alert: Paradigm ambulatory insulin infusion pumps manufactured by Medtronic (MDA/2013/035)
This Medical Device Alert has been issued due to a risk of compromised insulin therapy, which may lead to severe hypoglycaemia (low blood glucose) or severe hyperglycaemia (high blood glucose).
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14 May 2013 | Medical Device Alert: RÜSCH Macintosh laryngoscopes manufactured by M.A. Arain & Brothers (PVT) Ltd and distributed in the UK by Teleflex (RÜSCH) (MDA/2013/034)
This Medical Device Alert has been issued as there is the potential for the light to flicker or fail when using RÜSCH Macintosh laryngoscopes manufactured by M.A. Arain & Brothers (PVT) Ltd during intubation due to a loose connection between the battery and the battery cap.
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10 May 2013 | Medical Device Alert: Diacap® Ultra dialysis fluid filter manufactured by B. Braun Avitum AG (MDA/2013/033)
This Medical Device Alert has been issued due to a risk of a gradual increased fluid removal when using Diacap® Ultra dialysis fluid filters manufactured by B. Braun Avitum AG.
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09 May 2013 | Medical Device Alert: Defibrillators/monitors used for external pacing with non-invasive transcutaneous pacemaker modules - all manufacturers and all models (MDA/2013/032)
This Medical Device Alert has been issued due to a risk of inadequate external pacing, leading to potential periods of asystole, syncope and possible death.
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09 May 2013 | Medical Device Alert: Hospital beds: Dynamis and Gerialit with Dewert electrical control systems manufactured by Hill-Rom (MDA/2013/031)
This Medical Device Alert has been issued due to the risk of serious injury to patients, staff and visitors when using hospital beds manufactured by Hill-Rom.
