Field Safety Notices: 12 to 16 April 2021
Summary list of field safety notices (FSNs) from medical device manufacturers from 12 April to 16 April 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.
Latest FSNs
View the latest FSNs
View a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Arcoma: Intuition, Aceso, Omnera 400T
April 2021
X Ray, general
MHRA reference: 2021/003/023/601/001
Baxter: CWP 800 RO1 220-240V/ 380-415V, CWP 800 RO2 220-240V/ 380-415V, CWP 800 HW 220-240V/ 380-415V
14 April 2021
Dialysis, haemodialysis
Model: 115641, 115642, 115645
MHRA reference: 2021/004/012/487/018
Arjo: Nimbus 4 & Nimbus Professional
13 April 2021
Mattresses - Active/Passive And Overlays
Model: 650001ADV, 650001DAR, 650001P, 650201DAR, 651001, 651001ADV, 651001DAR, 651001DARW, 651001P, 651201DAR, 651201P
MHRA reference: 2021/004/013/601/001
Baxter: CWP 800 RO1 220-240V/ 380-415V, CWP 800 RO2 220-240V/ 380-415V, CWP 800 HW 220-240V/ 380-415V
14 April 2021
Dialysis, haemodialysis
Model: 115641, 115642, 115645
MHRA reference: 2021/004/012/487/018
Boston Scientific: POLARSHEATH Steerable Sheath 12F
13 April 2021/ 92688876-FA
Vascular cannula and catheters
Model: M004CRBS3050
MHRA reference: 2021/004/013/291/013
Boston Scientific: VICI VENOUS STENT and VICI RDS Stent Systems
April 2021/92672766-FA
Implants, non-active, peripheral vascular stents
MHRA reference: 2021/004/012/291/004
Boston Scientific: Upsylon Y Mesh Kit with Colpassist
April 2021
Implants, non-active, implantable incontinence and prolapse devices
Model: M0068318220 **
MHRA reference: 2021/004/012/291/003
Cook Medical: Gunther Tulip Vena Cava Filter Retrieval Set
08 April 2021
Implants, non active, vena cava filters
MHRA reference: 2021/004/014/291/004
Diffuplast: DiMix - ExactaMix - Di Eto
April 20 2021
Feeding systems and tubes
Model note: only the following products listed in the FSN are supplied in the UK:
- Exacta Mix parenteral nutrition bags (see FSN for specific product codes and batch numbers)
- Di Mix parenteral nutrition bags (product codes T99000, T99021, T99022, T99023, T99025 and T99026, see FSN for batch numbers)
- Di Eto Top Fill 2000ml enteral nutrition bags (Product code 6020V, batch number I171)
MHRA reference: 2021/002/024/701/050
Drager: Evita V800, Evita V600, Babylog VN800, Babylog VN600
April 2021
Lung ventilators
MHRA reference: 2021/004/014/701/098
HemoSonics: QStat Cartridges
15 March 2021
Coagulation
MHRA reference: 2021/004/015/487/011
Kimal: Procedure Packs
12 April 2021
Surgical devices, non-powered
Model: K90/18, K38026, K39929, DE-K47175, KW-K30904, K26271, K26304/P1, K26285
MHRA reference: 2021/004/012/601/002
Liva Nova: Tubing set, heart-lung bypass
08 April 2021
Infusion & transfusion, heart lung circuits
MHRA reference: 2021/004/009/291/001
Medtronic: CareLink Programmer; CareLink Encore Programmer
April 2021/FA844 Phase V
Implants, active, cardiac programmers and remote monitoring
Model: 2090, 29901
MHRA reference: 2021/004/008/291/001
Medtronic: Azure, Astra IPGs and Percepta, Serena, Solara CRT-Ps
April 2021/FA971
Implants, active, pacemakers
Model: W2DR01; W3DR01; W2SR01; W3SR01; X2DR01; X2SR01; W1TR04, W4TR04; W1TR05, W4TR05; W1TR06, W4TR06 Azure XT DR MRI: W2DR01 (47265) Azure S DR MRI: W3DR01 (47265) Azure XT SR MRI: W2SR01 (47267) Azure S SR MRI: W3SR01 (47267) Astra XT DR MRI: X2DR01 (47265) Astra XT SR MRI: X2SR01 (47267) Percepta CRT-P MRI: W1TR04; Percepta Quad CRT-P MRI: W4TR04 (47263) Serena CRT-P MRI: W1TR05; Serena Quad CRT-P MRI: W4TR05 (47263) Solara CRT-P MRI: W1TR06; Solara Quad CRT-P MRI: W4TR06 (47263)
MHRA reference: 2021/004/008/291/003
Medtronic: CareLink Smart Sync Device Manager: 24970A
April 2021/FA972
Implants, active, cardiac programmers and remote monitoring
Model: 24970A
MHRA reference: 2021/004/008/291/002
MicroPort: SYMPHONY/RHAPSODY
01 April 2021
Implants, active, pacemakers
Model: Symphony DR 2550, Symphony SR 2250, Symphony D 2450, Symphony VDR 2350, Rhapsody DR + 2530, Rhapsody DR 2510, Rhapsody SR 2210, Rhapsody D 2410, Rhapsody S 2130
MHRA reference: 2021/004/013/291/001
Optimed: Cemento Mini Set for Cemento-MP
06 April 2021
Bone cement and tools
Model: 1382-0100
MHRA reference: 2021/004/012/701/014
Prevor: DIPHOTERINE and HEXAFLUORINE
19 March 2021
Detergents
Model: DAP
MHRA reference: 2021/004/002/701/007
QIAGEN 100500: NeuMoDx Saliva Collection Kit
100500
IVDs, clinical chemistry
MHRA reference: 2021/004/014/701/116
Richard Wolf: LASER FIBER DISPOSABLE and REUSABLE
01 April 2021
Therapy, lasers
Model: 87501200, 87501272, 87501550, 87501800, 875011000
MHRA reference: 2021/004/013/291/012
Roche: IRON 2
April 2021
IVDs, clinical chemistry
MHRA reference: 2021/004/013/291/011
Siemens Healthineers: Artis zee ceiling
March 2021/AX008/20/S, AX011/20/S
X Ray, fluoroscopy systems
MHRA reference: 2021/004/001/601/023
Siemens Healthineers: ARTIS icono/ pheno systems with software VE20C
March 2021/AX023/21/S
X Ray, fluoroscopy systems
MHRA reference: 2021/003/024/601/002
Siemens Healthineers: AXIOM Artis / Artis zee / Artis Q / Artis Q.zen
March 2021/AX068/20/S
X Ray, fluoroscopy systems
MHRA reference: 2021/004/001/601/024
Smith & Nephew: OXINIUM 12/14 TAPER FEMORAL HEAD
08 April 2021
Joint prosthesis, hip
MHRA reference: 2021/004/015/487/010
Stryker: Smart Life Large Aseptic Housings
April 2021
Surgical power tools
Model: 7126-120-000
MHRA reference: 2020/012/001/487/002
Vapotherm: Oxygen Assist Module (OAM)
09 February 2021
Humidifiers
Model: PF-OAM-MAS; PF-OAM-NEL
MHRA reference: 2021/004/010/701/004