Ref: 2024/2686 - 19 December 2024
Important Customer Notice Status Update Type Product Alert
Philips Respironics has issued an update to the Field Safety Notice, 2024-CC-SRC-013, regarding Trilogy Evo, Trilogy Evo O2, Trilogy EV300, Flow Sensor Nebulized Aerosol Deposition previously communicated in September 2024.
Find out more
Ref: 2024/2771 - 17 December 2024
Important Customer Notice Status New Type Product Alert
Altomed has issued a Field Safety Notice following a customer advising receipt of a box of Iris Retractors without an expiry date on the outer carton. The internal pouch had the correct expiry date.
Find out more
Ref: 2024/2572 - 27 November 2024
Important Customer Notice Status Update Type Product Alert
Baxter has issued an updated Field Safety Correction Notice for the power cords used with the Welch Allyn ProBP 3400 Digital Blood Pressure Device and Welch Allyn Spot Vision Screener following reports of an issue relating to the cord construction not meeting the insulation rating for international standards.
Find out more
Ref: 2024/2757 - 27 November 2024
Important Customer Notice Status New Type Product Alert
Nihon Kohden has issued a Field Safety Corrective Action for its Recording Paper models NKUK-A054 and NKUK-MLSC-125 for Electrocardiographs due to incorrect labelling.
Find out more
Ref: 2024/2731 - 5 November 2024
Important Customer Notice Status New Type Product Alert
Olympus has issued a Field Safety Notice having become aware that five lot numbers may be missing product identification and an expiration date on the sterile packaging.
Find out more
Ref: 2024/2689 - 17 October 2024
Important Customer Notice Status New Type Product Alert
NHS Supply Chain has been made aware of two Field Safety Notices issued by Baxter on 26 June 2024 and 26 September 2024, due to Baxter identifying that the Braun Thermoscan Pro 6000 ear thermometers issued between 15 September 2022 and 22 February 2024 were supplied with a compact disc (CD) containing an outdated version of the instructions for use (IFU).
Find out more
Ref: 2024/2621 - 30 September 2024
Important Customer Notice Status Update Type Product Alert
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).
Find out more
Ref: 2024/2671 - 17 September 2024
Important Customer Notice Status New Type Product Alert
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.
Find out more
Ref: 2024/2596 - 5 September 2024
Important Customer Notice Status Update Type Product Alert
The Medicines and Healthcare products Regulatory Agency has issued the following device safety information update dated 4 September 2024.
Find out more
Ref: 2024/2656 - 30 August 2024
Important Customer Notice Status New Type Product Alert
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.
Find out more
Ref: 2024/2627 - 6 August 2024
Important Customer Notice Status New Type Product Alert
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.
Find out more
Ref: 2024/2493 - 5 August 2024
Important Customer Notice Status Update Type Product Alert
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.
Find out more
Ref: 2024/2617 - 25 July 2024
Important Customer Notice Status New Type Product Alert
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.
Find out more
Ref: 2024/2609 - 17 July 2024
Important Customer Notice Status New Type Product Alert
Nikkiso has issued a Field Safety Notice following discovery during product surveillance of a potential problem which could affect product performance.
Find out more
Ref: 2024/2528 - 19 June 2024
Important Customer Notice Status New Type Product Alert
Teleflex has issued an advisory Field Safety Corrective Action Notice for Teleflex Arrow FibreOptix and UltraFlex Intra-Aortic Balloon Catheter Kits.
Find out more