Field Safety Notices (FSNs) from 5 to 9 June 2023
List of Field Safety Notices (FSNs) from 5 to 9 June 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 . FSNs before this date are on the
Altomed: Damato Ruthenium Plaque Template
26 May 2023
Eye brachytherapy plaque-/applicator-positioning
Model: A7075CIB, A7075CIA, A7075COC
MHRA reference:
Baxter: Allen Advance Chest Support w/pad
06 June 2023
Surgical positioning spine board
MHRA reference:
Beckman Coulter: DxI 9000 Access Immunoassay Analyzer
31 May 2023
Chemiluminescent immunoassay analyser IVD, automated
MHRA reference:
bioM茅rieux: EBV R-GENE - BK Virus R-GENE
05 June 2023
MHRA reference:
Click Medical: RevoLock Align Kits and RevoLock 4-Hole Kits
22 May 2023
Model: threaded insert and snap
MHRA reference:
Macopharma: Single or multiple blood bag with LCRD2 filter
02 June 2023
In-line red cell filtration system
MHRA reference:
Medical Innovation Development: Medical Innovation Development / MIDBAND
05 May 2023
Gastric Band
Model: Adjustable Gastric Band
MHRA reference:
Medtronic: Vanta with AdaptiveStim Technology
FA1340 June 2023
Spinal cord/peripheral nerve implantable analgesic
Model: 977006
MHRA reference:
Medtronic: Cytosponge Cell Collection Device
June 2023
Cytology Scraper, single use
Model: CYTO-201
MHRA reference:
Philips: Azurion, Allura Xper
12 June 2023
Interventional Fluoroscopic X-Ray System
Model: 722010, 722012, 722022, 722023, 722026, 722028, 722033, 722035, 722079, 722224
MHRA reference:
Philips: HeartStart Intrepid Monitor/Defibrillator
16 May 2023
Defibrillators
Model: 867172
MHRA reference:
Poly Medicure: Polyflush Syringe, 0.9% Sodium chloride (0.9% NaCl), (Saline Solution Pre-Filled Syringes Single Sterile)
18 May 2023
MHRA reference:
Therapy Equipment: 0-15LPM Diamond Flowmeter
FSCA 2022-1_9505 Diamond Flowmeter
Diamond Flowmeter
Model: 9505
MHRA reference:
Thermo Fisher Scientific: Bilirubin Total (DCA)
01 June 2023
Total bilirubin IVD, kit, spectrophotometry
MHRA reference:
Thermo Fisher Scientific: RapID STR System
02 June 2023
MHRA reference:
Zimmer Biomet: Betta Link
23 April 2023
MHRA reference: