Field Safety Notices: 2 to 6 October 2023
List of Field Safety Notices from 2 to 6 October 2023.
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 .
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View . FSNs before this date are on the .
Abbott: CardioMEMS Patient Electronic System / HCP Letter
October 2023
Implantable pulmonary artery pressure monitoring
Model: CM1100
MHRA reference:
Abbott: CardioMEMS Patient Electronic System / Patient Letter
October 2023
Implantable pulmonary artery pressure monitoring
Model: CM1100
MHRA reference:
Arthrex: Knee Scorpion
17 August 2023
Suturing unit, reusable
Model: AR-12990
MHRA reference:
Boston Scientific: EXALT Model D Single-Use Duodenoscope
03 October 2023
Flexible video duodenoscope, single-use
MHRA reference:
GE Healthcare: Venue Go
28 September 2023
Ultrasound system, imaging, general-purpose
MHRA reference:
Getinge: APERLAN PY AGENT A, APERLAN PY AGENT B
04 August 2023
Disinfectant, medical device
MHRA reference:
Getinge: CARDIOHELP Emergency Drive
05 October 2023
Heart-lung bypass System
Model: 701048002; 701076205
MHRA reference:
Getinge: CARDIOHELP-I
22 August 2023
Heart-lung bypass System
Model: 701048012, 701072780 (US Variante)
MHRA reference:
Haemonetics: SAFETRACE TX
06 October 2023
Model: software Version 4
MHRA reference:
Integra: Codman CereLink ICP Monitor
21 September 2023 FSN 2022-HHE-006 A
Intracranial pressure monitor
Model: 826820
MHRA reference:
Integra: Codman CereLink ICP Monitor
21 September 2023 FSN 2022-HHE-006 B
Intracranial pressure monitor
Model: 826820
MHRA reference:
Roche: Accu-Chek Solo reservoir / HCP Letter
11 September 2023
GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS
MHRA reference:
Roche: Accu-Chek Solo reservoir / Patient Letter
11 September 2023
GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS
MHRA reference:
Stryker: UNIVERSAL JOINT SCREWDRIVER
2 October 2023
MHRA reference: 2023/009/025/601/033
Vitalograph: BVF
30 August 2023
Model: 2820
MHRA reference:
Updates to this page
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Added Haemonetics: SAFETRACE TX to FSN
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First published.