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With an effective date of January 1st 2019, a Field Safety Notice (FSN) was issued by the MHRA advising that a User Guide Change is implemented for Schiller CARDIOVIT MS-2007/MS-2010/MS-2015 electrocardiograph (ECG) units used for recording, analysis and evaluation of ECGs. Recording can be used as a diagnostic aid for heart function and heart conditions. The same battery AT102+ is used in all 3 machines.
Investigation had showed that the replacement of batteries in some of these units was overdue, some having been in service for over 5 years.
Where batteries aren’t replaced at the recommended interval, batteries may overheat resulting in smoke generation and the deformation of the battery housing.
To reduce these minor risks, the FSN states that the User shall respect the replacement interval for the batteries and according to the User Guide, the lifetime of these batteries is 24 months and the battery shall be replaced with a 24 month interval and be inspected in line with the User Guide.
It is suggested that the batteries are checked on all Schiller CARDIOVIT MS-2007/MS-2010/MS-2015 machines to ensure that the batteries installed are no more than 24 months old and that any batteries that have been in place for more than 24 months are immediately replaced.
For further information or to discuss our range of Original Manufacturer medical batteries & Compatible medical batteries, Original Manufacturer medical accessories and general purpose Sealed Lead Acid/VRLA batteries contact our friendly & knowledgeable Customer Service team on 0116 2340567 or email firstname.lastname@example.org