Medical Device Alerts

MDAs are distributed to the NHS via the Department of Health's Safety Alert Broadcast System (SABS). MDAs remain valid unless they are updated or withdrawn. They are reviewed once they are five years old (and subsequently every five years) and the lists on this website are amended accordingly.

Latest Medical Device Alerts

• 04 Sep 2008| MDA/2008/064 - Obturator - Venflon IV cannula obturator manufactured by BD

  This Medical Device Alert has been issued due to a manufacturing problem which may result in cracks and holes in the packaging, which could compromise sterility.

• 01 Sep 2008| Monthly list of MDAs - 2008

  A month-by-month list of Medical Device Alerts that we have issued in 2008.

• 12 Aug 2008| MDA/2008/063 - Sonesta 6210 fluoroscopy procedure table manufactured by Stille

  This Medical Device Alert has been issued due to uncontrolled movement of this device caused by a short circuit in the handset.

• 04 Aug 2008| MDA/2008/062 - Emergency and transport EMS ventilator circuits manufactured by Galemed Corporation and supplied by Smiths Medical

  This Medical Device Alert has been issued further to the MHRA’s Medical Device Alert MDA/2007/080, issued in October 2007, Galemed has expanded its recall to include an additional lot number.

• 04 Aug 2008| MDA/2008/061 - Laboratory analyser - ADVIA Centaur CP immunoassay system, serial number 086-A001-XX, manufactured by Siemens Healthcare Diagnostics

  This Medical Device Alert has been issued as the probe may have failed to dispense sample with no subsequent error message.

• 04 Aug 2008| MDA/2008/060 - Carendo multi-purpose hygiene chair manufactured by Arjo

  This Medical Device Alert has been issued due to a risk of entrapment of genitalia.
  

• 31 Jul 2008| MDA/2008/059 - Blood glucose meters – Ascensia Contour (5-second) manufactured by Bayer Diabetes Care

  This Medical Device Alert has been issued as affected devices may show falsely high readings when testing samples from neonates less than 24 hours old.  This may mask hypoglycaemia.

• 30 Jul 2008| MDA/2008/058 - Medi-Tec Classic hoist manufactured by Aidservice Ltd

  This Medical Device Alert has been issued after the MHRA received reports of two incidents where the spreader bar detached from the boom of the hoist while it was in use.

• 28 Jul 2008| MDA/2008/057 - Urine collection bottle - 24 hour urine container manufactured by Technical Service Consultants Limited

  This Medical device Alert has been issued due to incompatibility between the neck and cap of the bottle which can cause leakage.

• 24 Jul 2008| MDA/2008/056 - Laboratory analysers and their associated assays - ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems, manufactured by Siemens Healthcare Diagnostics, serial numbers 078-A001-XX and XP 078-A010-XX

  This Medical Device Alert highlights an issue with the ADVIA Centaur and ADVIA Centaur XP systems which may fail to alert the user when the wash 1 bottle is nearly empty. This may lead to incorrect test results in high risk biomarkers.