Medical device alerts archived in March 2018
Following our latest review of medical device alerts, we have archived the ones listed below.
Reference | Title |
MDA/2007/034 | Flexible endoscopes manufactured by Olympus, distributed in the UK by KeyMed Limited. |
MDA/2010/052 | Anaesthetic vaporizers used to administer volatile agents for the maintenance of anaesthesia - all manufacturers. |
MDA/2012/031 | Anaesthetic machines and associated devices, all manufacturers. |
MDA/2013/002 | Medical oxygen and medical air cylinders filled to 200 atmospheres - may cause damage to other devices. |
MDA/2013/014 | Oxoid antimicrobial susceptibility testing discs (AST) manufactured by Thermofisher Scientific. |
MDA/2014/001 | OPTEASE® retrievable vena cava filter, manufactured by Cordis Corporation. Lots with number 15960131 or below. |
MDA/2015/005 | CEM nosecones for use with CUSA® Excel/Excel+ ultrasonic aspirator. Manufactured by Integra LifeSciences. |
MDA/2015/012 | INRatio® and INRatio®2 PT/INR coagulation monitor and test strips used at home and at point of care. Manufactured by Alere. |
MDA/2015/019 | All Birdie mobile hoists (lifters). |
MDA/2015/023 | Kent and Ascot baths with a transfer seat and shepherd’s crook / shower pole fitted. Manufactured by Care in Bathing Ltd. |
MDA/2016/001 | Various nebulizers and nebulization kits – risk of nebulizer not delivering therapy to the patient. |
MDA/2016/003 | All ZeniPower mercury-free hearing aid batteries – low risk of batteries exploding during use or if depleted. |
MDA/2016/004 | Estradiol immunoassays – interference from the drug fulvestrant (Faslodex®) may cause falsely elevated estradiol results. |
MDA/2016/005 | Accu-Chek® Insight insulin pump system, manufactured by Roche Diabetes Care – risk of inappropriate treatment. |
MDA/2016/006 | CADD® administration sets with Flow Stop free-flow protection manufactured by Smiths Medical ASD – risk of under-infusion. |
MDA/2016/008 | Clinical chemistry tests: Siemens ADVIA Chemistry and Dimension/Dimension Vista products – risk of false low results due to interference with N-acetylcysteine (NAC). |
MDA/2016/009R | Home use blood glucose monitoring system: TRUEyou blood glucose test strips – risk of false low blood glucose results. |
MDA/2016/010 | RightSign HIV 1.2.O Rapid Test Cassette, HCV Rapid Test Cassette & HBsAg Rapid Test. Cassette – devices may give incorrect results that could lead to a missed diagnosis. |
MDA/2016/011 | Babytherm® 8004/8010 Infant Warmer, manufactured by Drägerwerk AG & Co – risk of fire. |
MDA/2016/012 | VentStar Oxylog3000F (P) 190 Disposable paediatric ventilation circuit for Oxylog 3000 and Oxylog 3000 plus ventilators – risk of rebreathing exhaled gases. |
MDA/2016/013 | SerenoCem Granules – risk of bone reabsorption around granules. |
MDA/2016/014 | Home use blood glucose monitoring system: TRUEresult and TRUEtrack blood glucose test strips – risk of false low blood glucose results. |
MDA/2016/015 | Accu-Chek® Insight insulin pump system manufactured by Roche Diabetes Care with NovoRapid® PumpCart® cartridges – risk of hyperglycaemia. |
MDA/2016/017 | AIRVO™2 and myAIRVO™2 humidifier – risk of undetected auditory alarm. |