Field Safety Notices: 18 to 22 January 2021
List of field safety notices (FSNs) from medical device manufacturers from 18 January to 22 January 2021
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.
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Boston Scientific: Sensation, Captivator, Captivator II, Captiflex
January 2021
Surgical instruments, minimal access
MHRA reference:
Depuy Synthes: Pinnacle Hip System
23 December 2020
Joint prosthesis, hip
MHRA reference:
Dr盲ger: Dr盲ger Neo disposable breathing systems
January 2021
Breathing system components
Model: MP00333, MP00353, MP00363, MP01327, MP01328
MHRA reference:
Getinge: Customized Tubing Set
19 January 2021
Infusion & transfusion, heart lung circuits
Model: Multiple perfusion sets
MHRA reference:
Getinge: SoKINOX; SERVINO
20 January 2021
Lung ventilators
Model: SoKINOX NO Delivery and Monitoring System
MHRA reference:
Intersurgical: Neonatal Resuscitation systems
297478
Breathing system components
MHRA reference:
LARS (Corin): LARS
PER 3297
ligaments, tendons and anchors
Model: 104.141
MHRA reference:
Medtronic FA908: HVAD鈩� Pump Implant Kit, HVAD鈩� Pump Outflow Graft, HVAD鈩� Implant Accessories Kit. HVAD鈩� Pump Surgical Tools, HVAD鈩� Pump Surgical Tools 鈥� extended length
January 2021
Implantable ventricular assist devices
Model: 1104, 1125, 1153, 1318, 1328
MHRA reference:
Medtronic: Strata II, Delta and Flow Control Valve
January 2021
Implants, non active, hydrocephalus shunts
Model: Class IIb
23093, 24048, 24053, 27102, 27219-1, 27219-2, 27219-5, 42312, 42314, 42316, 42322, 42324, 42326, 42355, 42365, 42414, 42532, 42534, 42542, 42544, 42546, 42812, 42813, 42814, 42822, 42823, 42824, 42836, 42856, 42866, 92322, 92324, 92856, 92866.
Class III 22011 L, 22011 M, 25131-1, 25131-2, 25131-5, 25132-2, 25132-5, 44420, 44421, 44430, 46622, 46624, 46642, 46644, 9003 A, 9003 B, 9003 C, 9003 D, 9003 E, 9003 F, 9040 A, 9040 B, 9040 C, 9040 D, 9040 E
MHRA reference:
Neuromedex (Delta): EVD connector NRFit, sterile (59-1005NR; 59-1006NR; 59-1007NR
19 January 2021
Cerebrospinal fluid drainage, external
MHRA reference:
Nihon Kohden: NIHON KOHDEN
January 2021
Electrophysiology measurement
Model: ORG-9100K
MHRA reference:
NuVasive: Precice devices including all versions including the Stryde
20 January 2021
Osteosynthesis, nails intramedullary
MHRA reference:
Philips Medical Systems: Philips-EPIQ Ultrasound system
11 January 2021
Ultrasound, imaging
Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi
MHRA reference:
Philips Respironics: Trilogy Evo, Trilogy Evo O2 and EV300, PLEASE NOTE, This is a customer letter rather than an FSN
January 2021
Lung ventilators
MHRA reference:
Sartorius Stedim Biotech: Minisart庐 NML / Ophthalsart
15 January 2021
Injection devices
Model: 16555-Q, 17594-GJR, 16534-K, 17598-K, 17597-K, 16555-GUK, 17598-Q, 16555-Q, 16555-K, 17528-K
MHRA reference:
Siemens Healthcare: Atellica IM and ADVIA Centaur fPSA Calibrator
January 2021
IVDs, clinical chemistry
MHRA reference:
STERIS: Reliance Vision Single Chamber Washer Disinfector
30 November 2020
Cssd wash/clean/drying equipment
MHRA reference:
ThermoFisher Scientific: EliA dsDNA Well
07 December 2020
VDs, immunology
Model: 14-5500-01
MHRA reference:
TR Equipment: TR Equipment
07 December 2020
Hoists and slings
Model: TR9650
MHRA reference:
VOCO: Rebilda Post Set
12 January 2021
Implants, dental
MHRA reference: