Tympanic thermometers – revision of the calibration frequency of Cardinal Health Genius 2 and Genius 3 models
Manufactured by Cardinal Health – calibration period revised to 25 weeks instead of yearly to ensure these thermometers remain within their accuracy range and reduce the risk of misdiagnosis or delay in treatment.
MDA number
MDA/2020/009
Summary
Manufactured by Cardinal Health – calibration period revised to 25 weeks instead of yearly to ensure these thermometers remain within their accuracy range and reduce the risk of misdiagnosis or delay in treatment.
Action
- Inspect your inventory for the affected product codes, serial numbers and date of manufacture – see the manufacturer’s Field Safety Notice for details.
- If you DO have access to a Genius checker/calibrator, calibrate all affected Genius thermometers.
- Following calibration, contact your Cardinal Health representative to arrange for a software update on your Genius checker/calibrator.
- Once the updated Genius checker/calibrator has been returned to your organisation, recalibrate all thermometers.
- If you DO NOT have access to a Genius checker/calibrator, contact your Cardinal Health representative.
- Amend your procedures to reflect the change in frequency of calibration and ensure that the latest versions of the instructions for use are available.
- Return the acknowledgment form in the Appendix to Cardinal Health.
Action by
Healthcare professionals who use these devices.
Deadlines for actions
Actions underway: 12 March 2020
Actions complete: 23 April 2020
Medical Device Safety Officers (in England): ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.
Remember: if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA
Device details
Device Identifier GTIN:
Genius 2 Tympanic Thermometer – 20884521099798
Genius 3 Tympanic Thermometer – 10884521738522
- Manufacturer item code: 303000
- Description: Genius 2 Tympanic Thermometer (discontinued)
- Affected product: All product manufactured after 01 October 2016, Serial Numbers N16598087 and above
- Manufacturer item code: 303013
- Description: Genius 3 Tympanic Thermometer
- Affected product: All product manufactured after 04 December 2017, Serial Numbers N17700101 and above
Background
Cardinal Health issued a Field Safety Notice but have had a poor response from end users acknowledging its receipt.
Manufacturer contacts
Cardinal Health Tel: 00800 844 77 384 option 2 / 020 3795 9970 option 2
GMB-CASHEL-RA@cardinalhealth.com
Distribution
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland) CAS and NICAS liaison officers for onward distribution to all relevant staff including:
- A&E consultants
- A&E departments
- A&E directors
- A&E nurses
- Adult intensive care units
- Ambulance services directors
- Ambulance staff
- Audiology departments
- Biomedical engineering staff
- Cardiac laboratory technicians
- Cardiologists
- Cardiology departments
- Cardiology nurses
- Cardiology, directors of
- Cardiothoracic departments
- Cardiothoracic surgeons
- Cardiothoracic surgery directors
- Clinical governance leads
- Colposcopy departments
- Community children’s nurses
- Community hospitals
- Community midwives
- Community nurses
- Coronary care departments
- Coronary care nurses
- District nurses
- EBME departments
- ENT departments
- ENT medical staff
- ENT services, directors of
- Equipment stores
- Equipment libraries and stores
- General surgery
- General surgical units, directors of
- Gynaecology departments
- Haematologists
- Haemodialysis nurses
- Haemodialysis units
- Health visitors
- Hospital at home units
- Immunisation co-ordinators
- Infection control departments
- Infection control nurses
- Infection prevention and control directors
- In-house maintenance staff
- Intensive care medical staff/paediatrics
- Intensive care nursing staff (adult)
- Intensive care nursing staff (paediatric)
- Intensive care units
- Intensive care, directors of
- Maintenance staff
- Minor injury units
- Maternity units
- Maxillofacial departments
- Medical directors
- Medical libraries
- Medical physics departments
- Midwifery departments
- Midwifery staff
- Neonatal nurse specialists
- Neonatology departments
- Neonatology directors
- NHS walk-in centres
- Nursing executive directors
- Obstetrics and gynaecology departments
- Obstetrics and gynaecology directors
- Obstetrics departments
- Obstetrics nurses
- Occupational health departments
- Oncology nurse specialists
- Operating department practitioners
- Ophthalmic nurses
- Ophthalmology departments
- Ophthalmology, directors of
- Oral surgeons
- Orthopaedic surgeons
- Outpatient clinics
- Outpatient theatre managers
- Outpatient theatre nurses
- Paediatric intensive care units
- Paediatric medicine, directors of
- Paediatric nurse specialists
- Paediatric oncologists
- Paediatric surgeons
- Paediatric surgery, directors of
- Paediatric wards
- Paediatricians
- Paediatrics departments
- Palliative care teams
- Paramedics
- Peritoneal dialysis units
- Radiation & medical oncology departments
- Renal medicine departments
- Renal medicine, directors of
- Risk managers
- School nurses
- Special care baby units
- Staff supporting patients receiving haemodialysis at home
- Supplies managers
- Theatre managers
- Theatre nurses
- Theatres
- Urological surgeons
- Urological surgery, directors of
- Urology departments
- Walk-in centres
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- General practice managers
- General practice nurses
- General practitioners
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
- Adult placement
- Care homes providing nursing care (adults)
- Clinics
- Domiciliary care providers
- Hospices
- Hospitals in the independent sector
- Independent treatment centres
- Private medical practitioners
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Central Alerting System (CAS) by sending an email to: safetyalerts@mhra.gov.uk and requesting this facility.
Enquiries
England
Send enquiries about this notice to MHRA, quoting reference number MDA/2020/009 or 2019/010/031/291/004.
Technical aspects Dr Philip Davenport or Andy Marsden, MHRA Tel: 020 3080 6461 / 7205 Email: DSS-TM@mhra.gov.uk
Clinical aspects Devices Clinical Team, MHRA Tel: 020 3080 7274 Email: dct@mhra.gov.uk
To report an adverse incident involving a medical device in England use the Yellow Card reporting page
Northern Ireland
Northern Ireland Adverse Incident Centre (NIAIC), CMO Group, Department of Health (Northern Ireland) Tel: 028 9052 3868 Email: niaic@health-ni.gov.uk To report an adverse incident involving a medical device in Northern Ireland use the forms on the website. Alerts in Northern Ireland are distributed via the NICAS system.
Scotland
Incident Reporting and Investigation Centre (IRIC), Health Facilities Scotland, NHS National Services Scotland Tel: 0131 275 7575 Email: nss.iric@nhs.net To report an adverse incident involving a medical device in Scotland, email IRIC to request a webform account. For more information, or if you can’t access the webform, visit the website: how to report an adverse incident
Wales
Population Healthcare Division, Welsh Government
Tel: 03000 255278 or 03000 255510
Email: Haz-Aic@gov.wales
To report an adverse incident involving a medical device in Wales, use the Yellow Card reporting page and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).
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