Field safety notices - 2 to 6 july 2018
Field safety notices - 2 to 6 july 2018"
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FIELD SAFETY NOTICES - 2 TO 6 JULY 2018 Summary List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 July 2018. OVERVIEW If you receive a field safety notice
(FSN) from a manufacturer you must always act on it. MHRA publishes the following for information only. If you have a question about a particular FSN contact the manufacturer. LATEST FSNS
View the latest FSNs CSC (DXC TECHNOLOGY): ILAB AKI 2.1 BUILD 5 26 June 2018 IVDs, clinical chemistry MHRA reference: 2017/002/014/701/015 CEPHEID: XPERT MTB/RIF ULTRA 14 June 2018 IVDs,
bacteriology MHRA reference: 2018/006/029/701/010 FRESENIUS: 5008 CORDIAX HD-PAED OPTION 26 June 2018 Dialysis, haemodialysis MHRA reference: 2018/007/005/291/001 GE MEDICAL SYSTEMS: REFER
TO THE FIELD "ACCESSORIES/ASSOCIATED DEVICE" 60936 Magnetic resonance, equipment & accessories MHRA reference: 2018/006/028/081/004 INTUITIVE SURGICAL: DA VINCI® SI™ / XI™ / X™
SURGICAL SYSTEM ISIFA2018-05-C Endoscopes, rigid Model: IS3000 / IS4000 / IS4200 Surgeon Side Console; IS3000 Patient Side Cart MHRA reference: 2018/006/028/701/018 MEDTRONIC: GUARDIAN™
CONNECT APPLICATION July 2018 Continuous glucose monitoring systems (CGMS) Model: CSS7200 MHRA reference: 2018/007/005/291/044 MEDTRONIC: VISUALASE™ THERMAL THERAPY SYSTEM June 2018 Magnetic
resonance, equipment & accessories Model: 9735542 MHRA reference: 2018/007/003/291/040 RAYSEARCH LABORATORIES: RAYSTATION 29 June 2018 IVDs, clinical chemistry Model: RayStation 4.5,
RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A MHRA reference: 2018/007/002/701/021 ROCHE 25 June
2018 Cobas p612 pre-analytical system (LCP1) Model: 07563116001 MHRA reference: 2018/006/029/701/006 SIEMENS: ATELLICA IM 1300 ANALYZER /ATELLICA IM 1600 ANALYZER /ATELLICA CH 930 ANALYZER
/ATELLICA SAMPLE HANDLER PRIME / ATELLICA SAMPLE HANDLER CONNECT / ATELLICA SAMPLE HANDLER ADDITIONAL June 2018 IVDs, clinical chemistry MHRA reference: 2018/007/003/601/008 THERMO FISHER
SCIENTIFIC: THERMO SCIENTIFIC EZ SINGLE CYTOFUNNEL 04 January 2018 IVDs, cytopathology & histopathology Model: A78710004 MHRA reference: 2018/007/002/601/002 THERMO FISHER SCIENTIFIC:
GIBCO™ RPMI 1640 MEDIUM 19 June 2018 IVDs, bacteriology MHRA reference: 2018/007/004/291/001 WEINMANN EMERGENCY MEDICAL: WM 28300 UND WM 28400 02 July 2018 Lung ventilators MHRA reference:
2018/007/003/291/032 UPDATES TO THIS PAGE Published 9 July 2018
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