Field Safety Notice: Discontinuation of Technical Support for h/p/cosmos airwalk® Body Weight Support Systems

Issued by HaB Direct Ltd, UK distributor for h/p/cosmos.

Date of issue: January 2026

FSN reference: HBD-FSN-AIRWALK-0126.

Affected devices

This Field Safety Notice applies to the following h/p/cosmos airwalk® body weight support systems:

h/p/cosmos article numberArticle name
cos100073body weight support device h/p/cosmos airwalk 35
cos100074body weight support device h/p/cosmos airwalk 70
cos100075body weight support device h/p/cosmos airwalk 160
cos100075-01body weight support device h/p/cosmos airwalk 160
cos10091body weight support device h/p/cosmos airwalk 35
cos10092body weight support device h/p/cosmos airwalk 50
cos10093body weight support device h/p/cosmos airwalk 90
cos101430body weight support device h/p/cosmos airwalk 75

Description of the issue

h/p/cosmos has informed HaB Direct that technical support for the above airwalk® systems has been discontinued with immediate effect.

These devices were marketed as Class I medical devices under Directive 93/42/EEC and are used to provide partial body weight support during treadmill therapy and training.

Safe operation requires the regular replacement of the relief cable, at least once per year, as specified in the instructions for use. This spare part can no longer be supplied by the original manufacturer. As h/p/cosmos is not the manufacturer of the airwalk® systems, it cannot manufacture replacement parts without assuming manufacturer responsibility.

As a result, correct maintenance can no longer be ensured and technical support has therefore been withdrawn with immediate effect.

Actions required by operators

Operators should stop using the affected device if the prescribed maintenance cannot be carried out. All airwalk® systems in service should be reviewed against the affected article numbers and all relevant staff and users informed without delay.

If use is nevertheless continued on a temporary basis, this is entirely at the operator’s own risk and outside the scope of service and responsibility of both h/p/cosmos and HaB Direct.

Regulatory information for operators and distributors

Operators and distributors are reminded that medical devices may only be operated in a safe condition and maintained in accordance with the manufacturer’s instructions. If this is not possible, the device must not be used.

Distributors and operators may only supply or make available safe products. Unauthorised modifications or reproduction of spare parts may result in full manufacturer liability for the operator or distributor.

Further regulatory guidance is available from the UK Medicines and Healthcare products Regulatory Agency and from the EU Medical Devices Directive 93/42/EEC.

Additional safety recommendations

If a decision is made to continue use temporarily, the following measures are strongly recommended. The relief cable should be visually inspected for wear or damage before and after every use. The device should be taken out of service immediately if any damage is observed. All inspections and actions should be fully documented.

These measures do not restore manufacturer support or regulatory compliance.

Replacement and alternatives

As part of a replacement programme, h/p/cosmos is offering the MDR compliant h/p/cosmos airwalk® ap body weight support system at a preferred price. This system includes additional safety features and meets current regulatory requirements.

Further information on the airwalk® ap system is available from the manufacturer at https://www.h-p-cosmos.com/en/products/rehabilitation/airwalk-ap/

HaB Direct is available to discuss suitable alternatives and provide guidance on system upgrades.

Contact information

If you have questions regarding this Field Safety Notice, require assistance identifying affected devices, or would like to discuss replacement options, please contact HaB Direct directly. You can do so by emailing us at [email protected] or calling us on +44 (0)1926 816 100.

HaB Direct regrets any inconvenience caused and thanks all customers for their cooperation in maintaining patient and user safety.

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