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Important Customer Notices (ICNs)

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Showing 112 ICNs only belonging to tag: Field Safety Notice Clear filter

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Product Update GOJO Industries Hand Hygiene and Associated Products and Services (ICN 2523)

Ref: 2024/2523 - 3 October 2024

Important Customer Notice: Update

The recently updated product matrix reflects changes to the Hand Hygiene framework for products that have been delisted.

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Field Safety Notice Trilogy Evo, Trilogy Evo 02, Trilogy EV300 Flow Sensor Nebulised Aerosol Deposition (ICN 2686)

Ref: 2024/2686 - 3 October 2024

Important Customer Notice: Field Safety Notice

Philips Respironics has issued an urgent Field Safety Notice having become aware of a potential issue when using in-line nebulizers in certain configurations with Trilogy Evo, Trilogy Evo O2, and Trilogy EV300 devices. The use of in-line nebulizers placed in certain locations can result in aerosol deposits accumulating over time on the device’s internal flow sensor.

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Field Safety Notice Medtronic Healthcare21 McGrath Mac Video Laryngoscope FDD2504 (ICN 2621)

Ref: 2024/2621 - 30 September 2024

Important Customer Notice: Update

In July 2024, Medtronic issued an Urgent Field Safety Notice for McGRATH™ MAC Video Laryngoscopes, item codes 300-000-000, which were within their useful life of 5 years (Serial numbers 366170 to 405673).

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Product Recall Ambu VivaSight 2DLT  (ICN 2673)

Ref: 2024/2673 - 19 September 2024

Important Customer Notice: Recall

Ambu has issued a Field Safety Notice following complaints regarding the design of the product Ambu® VivaSight™ 2 DLT, specifically referring to a hyper angulation of the distal end of the double lumen tube.

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Field Safety Notice Intersurgical IPPB Flextube™ Breathing System (ICN 2671)

Ref: 2024/2671 - 17 September 2024

Important Customer Notice: Field Safety Notice

Intersurgical has issued a Field Safety Notice following a report of a loose connection between the nebuliser and supply line T-piece IPPB Flextube™ breathing system.

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Field Safety Notice Zimmer Biomet CPT® Hip System Femoral Stem 12/14 Neck Taper (ICN 2596)

Ref: 2024/2596 - 5 September 2024

Important Customer Notice: Update

The Medicines and Healthcare products Regulatory Agency has issued the following device safety information update dated 4 September 2024.

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Field Safety Notice TSC Life Fluido Trauma Standard Sets VCB522 (ICN 2656)

Ref: 2024/2656 - 30 August 2024

Important Customer Notice: Field Safety Notice

The supplier TSC Life have issued a Field Safety Corrective Action (FSCA) Notice following quality control testing which revealed a proportion of the tested samples to have elevated levels of non-toxic particulates in Fluido® single use sets.

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Field Safety Notice Olympus UHI-4 High Flow Insufflation Unit (ICN 2375)

Ref: 2023/2375 - 23 August 2024

Important Customer Notice: Update

Olympus has released a further update to inform customers about a further software update to correct the causes of over pressurization associated with the UHI-4.

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Product Recall Ossur Miami J Select PSA Hook Adhesion (ICN 2651)

Ref: 2024/2651 - 21 August 2024

Important Customer Notice: Recall

Ossur has issued a Field Safety Notice recalling two Miami J Select Cervical Collars following discovery that the pressure sensitive adhesive (PSA) hooks attached to the sides of the anterior collar panel can occasionally exhibit poor adhesion.

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Product Recall Smiths Medical BLUSelect™ Pilot Balloon Detachment (ICN 2645)

Ref: 2024/2645 - 16 August 2024

Important Customer Notice: Recall

Smiths Medical has issued an Urgent Field Safety Notice having identified a manufacturing defect with the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific Lots of the BLUSelect®, BLUgriggs® and BLUperc® products.

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Field Safety Notice BioDesign Fistula Plug Labelled Expiration Date Incorrect (ICN 2641)

Ref: 2024/2641 - 15 August 2024

Important Customer Notice: Field Safety Notice

Cook Medical has issued an Urgent Field Safety Notice following discovery of a discrepancy between the correct product shelf life and that printed on the finished product label.

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Product Recall Cepheid Specimen Collection Devices for GX (ICN 2638)

Ref: 2024/2638 - 12 August 2024

Important Customer Notice: Recall

Following reports of leakage after the patient samples swabs had been inserted into the test tubes, Cepheid has issued an Urgent Medical Device Product Recall for the product code listed below.

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Field Safety Notice Philips Trilogy Evo, Evo O2, EV300 Failing to Meet Obstruction Alarm Standards Requirement (ICN 2627)

Ref: 2024/2627 - 6 August 2024

Important Customer Notice: Field Safety Notice

Philips Respironics has become aware that Trilogy Evo, Trilogy Evo O2, and Trilogy EV300 devices do not comply with the Obstruction Alarm requirements specified within ISO 80601-2-12 Clause 201.12.4.108 and ISO 80601-2-72 Clause 201.12.4.107.

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Field Safety Notice Philips Trilogy Evo, Evo O2, EV300 Loss of Power Alarm (ICN 2493)

Ref: 2024/2493 - 5 August 2024

Important Customer Notice: Update

Philips Respironics has issued an update to the Field Safety Notice advising the release of a mandatory Software update, Version 1.06.10.00 and a User Manual addendum for the Trilogy Evo, Trilogy Evo O2, and the Trilogy EV300 ventilators.

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Field Safety Notice Micsafe GBUK Safety Hypodermic Needles Printing Error on Packaging (ICN 2617)

Ref: 2024/2617 - 25 July 2024

Important Customer Notice: Field Safety Notice

Micsafe Medical has issued a Field Safety Notice following discovery that the blister level of the packaging for two sizes of their safety hypodermic needles, has the expiry and manufacture dates transposed.

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Field Safety Notice Nikkiso Aqualine, Aquaset and Citraset Tubing Sets and Filters (ICN 2609)

Ref: 2024/2609 - 17 July 2024

Important Customer Notice: Field Safety Notice

Nikkiso has issued a Field Safety Notice following discovery during product surveillance of a potential problem which could affect product performance.

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