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03 Jan 2020

CLH Blog - MHRA Field Safety Updates For December 2019

CLH Blog - MHRA Field Safety Updates For December 2019

As always, we have researched the various field safety alerts that have been filed over the past month and have put together a roundup of the most relevant MHRA updates and recalls. These focus on recalls and updates on products and equipment that are relevant to UK care homes and other care facilities.

Please note that the updates mentioned below are all things listed with the Medicines and Healthcare products Regulatory Agency (MHRA) amongst other suppliers. Please also note that if you receive a field safety notice from a supplier, it is vital that you act on it immediately.

Trauma Sterile Tube (M size) 1655109 Synthes GmbH - Field Safety Notice

Synthes GmbH is initiating a voluntary field safety notice for all lots of Sterile Screw implants packed in Sterile Tubes with part numbers ending in suffix TS with inner tube components manufactured by Flex Precision Plastics

Solutions since June 17, 2019.

Product Info:

Sterile screw implants packed in Sterile Tubes (size M) with part numbers ending in suffix TS. Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. See attached list of affected product codes.

Reason for Field Safety Notification:

There is a possibility that:

1) the inner cap could open when the outer cap is removed (picture 1) or
2) the entire inner tube remains in the outer tube (picture 2)
In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner
tube should remain closed and retained in the outer cap when presented to the sterile field. 

FSN date: December 2019

Velara X-ray generator of the Philips Allura Xper system, the Integris system, the MultiDiagnost Eleva system and OmniDiagnost system - Field Safety Notice

Velara X-ray generator may fail and cause interruption of image acquisition. A problem has been detected with a capacitor inside the convertor of the Velara X-ray generator of the Philips Allura Xper system, the Integris system, the MultiDiagnost Eleva system and OmniDiagnost system, delivered from 2010 up till and including 2014.

Philips identified that a capacitor inside the convertor of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible anymore. The failed capacitor may produce smoke and a burning odor in the room where the generator is located.

The affected systems are those listed below and delivered from 2010 up till and including 2014.
Systems:

  • OmniDiagnost Eleva
  • MultiDiagnost Eleva with Flat Detector
  • Integris CV
  • Allura Xper FD10 Ceiling
  • Allura Xper FD10 Floor
  • Allura Xper FD10
  • Allura Xper FD10/10
  • Allura Xper FD20
  • Allura Xper FD20 Biplane
  • Allura Xper FD10
  • Allura Xper FD10/10
  • Allura Xper FD20
  • Allura Xper FD20 Biplane
  • Allura Xper FD10 OR Table
  • Allura Xper FD20 OR Table
  • Allura Xper FD20 Biplane OR Table
  • Allura Xper FD20 OR Table
  • Allura Xper FD10
  • Allura Xper FD10/10
  • Allura Xper FD20
  • Allura Xper FD20/10
  • Allura CV20
  • Allura Xper FD20 OR Table
  • Allura Xper FD20/20
  • Allura Xper FD20/20 OR Table
  • Allura Xper FD20/15
  • Allura Centron

Product codes:

708027, 708032, 708034, 708036, 708037, 708038, 722001, 722003, 722005,
722006, 722008,722010, 722011, 722012, 722013, 722014, 722015, 722020,
722023, 722026, 722027, 722028, 722029, 722030, 722031, 722035, 722038,
722039 and 722058.

FSN date: December 2019

CombiDiagnost R90 - Philips Medical Systems - Field Safety Notice

A problem has been detected with the CombiDiagnost Upgrade PCF systems to Rel. 1.0.5 + check of mains transformer thermo contact.

Description of the problem: Error 80 issue

The table can be tilted by pressing the corresponding + or - tilt motion buttons (“Table Tilt Left/Right“) or using the table up/down button (“Table Up/Down“). If using the Table Up/Down button, the table moves down and tilts back to horizontal position at the same time.

When using the Table Up/Down button, the system can experience Error 80, which locks the geometry in that specific state. System operation cannot be restored by system reboot, but requires the intervention of a service engineer. SPDU issue:

The SPDU (system power distribution unit) is the main power supply for the complete system without the x-ray generator. It contains a three-phase transformer with a power rate of about 7kVA, containing a thermo switch per phase to aid in powering down the unit in case of overheating. These switches may be incorrectly installed and not working. 

Description of the hazard: 

The hazard associated with this defect is that the system gets stuck in negative or positive tilt / table does not move anymore. When imaging using contrast agent, if the patient is lying on the table with legs elevated above the head, the contrast agent may enter the brain, causing a headache unless the patient is removed from the system.

If the transformer overheats due to a first failure and the thermo switch is not activated, the device may begin to generate smoke. Should this occur, there is a risk of smoke inhalation and related issues to patients, operators or bystanders.

FSN date: December 2019

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