Field Safety Notices for medical devices

We place them on our website for information and they will not normally require further action unless you have been contacted directly by the manufacturer or we have issued supplementary advice.

We began placing field safety notices on our website in response to requests from medical device and safety alert broadcast system liaison officers, to improve awareness of field safety corrective actions.

We review all field safety notices addressed to UK users of medical devices, and update their status as we continue to assess manufacturers' field safety corrective actions.

Regular users of these web pages may wish to register to receive e-mail alerts for all new field safety notices and status updates:
› E-mail alerting service

• 21 Nov 2008| Infant incubators: incubator - GE Healthcare Technologies - Giraffe Omnibed

  Changes/updates have been made to instructions for use.

• 21 Nov 2008| Monitors, patient: multi parameter monitor - Philips Medical Systems UK Limited - IntelliVue Patient Monitor Table Mount M8000-64100

  Device is to be exchanged.

• 21 Nov 2008| Surgical instruments, implant - Abbott Spine - PathFinder and InCompass T-Handle Driver

  Advice has been given by the manufacturer regarding the use of the device. Changes/updates have been made to instructions for use.

• 20 Nov 2008| Joint prosthesis, hip: femoral head - Comis Orthopaedics Ltd - MIHR Modular Femoral Head Sleeve Size 0, product code 028-10-2, specific lot numbers

  Devices have been exchanged. Changes/updates have been made to patient labelling.

• 20 Nov 2008| Implants, active, infusion pumps: continuous flow pump - Codman, A J&J Company - Archimedes implantable infusion pump

  Advice has been given by the manufacturer regarding the use of the device.

• 20 Nov 2008| Osteosynthesis, bone screws: screw - Smith & Nephew Healthcare Ltd - SoftSilk 1.5, 8mm x 20mm

  Device is to be exchanged. Return of the device to the manufacturer or its representative.

• 19 Nov 2008| Joint prosthesis, knee - Stanmore Implants Worldwide Ltd - METS Femoral Shaft

  Return of specified lots/batches of the device to the manufacturer or its representative. Device is to be exchanged.

• 19 Nov 2008| Urinary catheters and accessories: intermittent catheter - Coloplast A/S - Various EasiCath intermittent Neleton (Male and Boy) catheters and Tiemann (Male) catheters

  Return of the device to the manufacturer or its representative.

• 19 Nov 2008| Surgical instruments, manipulating - Clinical Innovations - ClearView Uterine Manipulator, regular and long, with Disposable Sound-Dilator (DSD-1000)

  Return of the device to the manufacturer or its representative.

• 19 Nov 2008| IVDs, clinical chemistry: instrumentation - Beckman Coulter UK Ltd - Power Processor with LX Connections, 6605741

  Hardware to be upgraded. Advice has been given by the manufacturer regarding the use of the device.