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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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