Toshiba ultrasound transducers 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2014/046

CON484998

2014-12-08

2014-12-08

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON484998?tabName=allTabs

Counterfeit ultrasound transducers have been supplied to 2 hospitals. these devices may not meet the performance specified by toshiba. there have been no reports of patient harm. transducers supplied directly by toshiba medical systems uk are not affected. mhra and toshiba will continue to investigate this matter as new cases appear.   the mhra has become aware that counterfeit toshiba ultrasound transducers have been found in two hospitals in the uk. as there is no evidence of patient harm, mhra is not recommending that patients are called back to their hospital or clinic. we are publishing this alert as a precautionary measure to raise awareness of the issue and to ask users to check toshiba ultrasound transducers not supplied direct from toshiba medical systems uk. as counterfeits may look very similar to legitimate products, they need to be checked very carefully.  however, a competent user should easily identify a fake transducer. in addition, the device should have undergone quality checks before being brought into use. these devices are also subject to periodic quality and maintenance checks. there is guidance for healthcare providers from ipem, sor and cqc on the procurement, initial acceptance testing, quality assurance and maintenance of these devices. this would mean that counterfeits should be identified before use.

Identify and quarantine any suspect devices. Further advice on how to identify fake devices is given on pages 2 and 3 of this alert. To authenticate suspected devices, contact your local Toshiba representative via their dedicated email report.counterfeit.uk@tmse.nl Report any counterfeit devices to the MHRA via Yellow Card Counterfeit transducers can be identified by one or more of the following characteristics: The label may be poorly attached and made of paper. It may also peel off easily and leave a residue. Toshiba labels are plastic or metal and are difficult to remove The descriptive text may be incorrect – a linear transducer array may be described as ‘convex’ Since 2005 Toshiba serial numbers are ten digits long e.g. TDA1293472. Any label with fewer numbers is likely to be counterfeit Scanning the QR code (if any) on the label will not take the user to a website or it gives a different probe type and serial number The Toshiba logo or wording may not be as sharp, and the casing may have a different finish when compared to a genuine probe Counterfeit Toshiba transducer heads can be substantially lighter in weight than genuine Toshiba items The pictures below are examples only to help identify suspected counterfeit probes. They do not represent all possible fake devices.