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Reference:
VF2026-0003 | SK2026-0001 | SF2026-0055 | ref260114-00289 | cos101418-02 | cos101000j | cos101000al | cos30001-01va02 | cos30001-01va02-0137
Vigilance Report BfArM:
03065/26
Manufacturer
h/p/cosmos sports & medical gmbh
Am Sportplatz 8
83365 Nussdorf-Traunstein
Germany
EUDAMED ID Economic Actor: SRN: DE-MF-000006147;safety@hpcosmos.com / www.hpcosmos.com
Contact PRRC: Nadine Schott, PRRC Art. 15 MDR nadine.schott@hpcosmos.com / +49 8669 86 42 0
Product category: Treadmill
Product name: Treadmill locomotion 150/50 DE med and locomotion 190/65 DE med
Product item no.: cos30001-01va02 (treadmill) and cos30024va04 (treadmill) | cos101418-02 (emergency stop switch)
Basic UDI-DI: B-40505880023050 and B-4050588002114
UDI-DI: 40505880023050 and 4050588002114
Risk class: IIb
EUDAMED code: Z129006: Treadmills for physiotherapy and/or diagnostic uses
FDA code: IOL, treadmill, powered exercise equipment, 510(K) Exempt, Regulation Number 890.5380
Countries affected: Austria | Spain | Germany | Great Britain | Ukraine | Morocco
Affected SN: cos30001-01va02-0142 | cos30001-01va02-0141 | cos30001-01va02-0139 | cos30001-01va02-0138 | cos30001-01va02-0140 | cos30001-01va02-0137 | cos30024va04-0005 | cos30001-01va02-0136 | cos30001-01va02-0135
To: All users, operators, dealers and service partners with locomotion 150/50 DE med and locomotion 190/65 DE med treadmills manufactured after 02/2025
Subject: Possible failure of the stop device to activate via the ripcord with clip and magnetic switch
!! The normal emergency stop button via mushroom button is still functional and not affected by this !!
Description:
According to the treadmill standard DIN EN ISO 20957-6, the ripcord is intended as a possible safety-related trigger for the emergency stop function.
A user recently reported to us that, in one of the 9 devices potentially affected when used with patients, this pull cord stop switch did not cause the treadmill belt to STOP.
The treadmill could and had to be stopped using the additional mushroom-shaped emergency stop button.
An internal review of this production batch of a maximum of nine devices revealed that there may be other h/p/cosmos treadmills from this production batch of nine devices where this additional ripcord emergency stop does not trigger reliably in all cases. This means that the required "emergency stop via ripcord" function is not guaranteed at all times. In a situation where immediate stopping is required, it may therefore not be possible to stop the treadmill using the ripcord. The running belt and/or lift motor will only stop when another emergency stop button (e.g. mushroom button, known as the "master emergency stop") that is also available on h/p/cosmos treadmills is activated.
Cause: In this production batch of 9 treadmills built from 2025 onwards with the old MCU5 user terminal, the rated current required for triggering was too high after a component change, so that the required triggering condition was not achieved in isolated cases. As a result, the ripcord may not trigger in certain situations, despite being activated.
Risk/hazards/safety assessment:
If the emergency stop trigger via the ripcord does not work, the treadmill cannot be stopped using this trigger type in a situation where immediate stopping would be necessary. This can prolong the reaction time until the treadmill comes to a standstill, unless another emergency stop is activated immediately. This can increase the risk of falls (e.g. loss of balance/stability, drifting backwards). The potential health risks include abrasions, bruises, sprains and, depending on the situation and patient, broken bones or head injuries. The consequences can be particularly serious for patients with limited mobility. Users also run the risk of having to intervene in an unexpected situation (e.g. supporting or holding the patient), which can lead to overexertion or injury. Third parties (e.g. accompanying persons) may also be affected by uncontrolled movements or collisions in the vicinity of the device.
It is also important to note that a ripcord is not a fall prevention system. It can stop the treadmill in an emergency, but it does not prevent a fall and therefore cannot replace fall protection. Assuming that the ripcord alone provides "fall protection" can lead to a false sense of security that does not exist in this form.
Therefore, depending on the patient and application, suitable fall prevention measures (e.g. airwalk ap with / safety bar with fall protection) are still required in cases where a fall could pose an unacceptable risk (osteoporosis, high-speed or special applications with persons who cannot jump off the treadmill, such as children, physically impaired persons, etc.).
Immediate measures:
- Check whether affected: Compare the serial number with the device list. If the device is affected, this FSN applies.
- Use only under supervision: The treadmill may only be operated if a trained caregiver is constantly present and can reach the emergency stop immediately at any time.
- Apply fall prevention: For gait therapy and in cases of increased risk of falling, suitable fall protection (e.g. airwalk ap with fall protection/safety bar) must be used.
- Quick check before each use: Test the emergency stop button including the ripcord before each use.
- Take out of service immediately if...
- the emergency stop does not stop immediately,
- there is a malfunction in the emergency stop chain, or
- safe supervision/accessibility of the emergency stop is not guaranteed.
- Carry out conversion promptly: After receiving the conversion kit, carry out the conversion (2x emergency stop left/right) according to the instructions, perform a function test according to the instructions and confirm by email.
Correction:
We are retrofitting the 9 treadmills in question with an optimised emergency stop control: In future, these 9 machines will have two easily accessible emergency stop controls (large mushroom buttons) – one on the left and one on the right handrail – in order to comply with the treadmill standard DIN EN ISO 20957-6. This allows the emergency stop to be triggered quickly and intuitively from both sides. As part of this improvement, the treadmill will then be operated without a ripcord. The emergency stop function remains fully guaranteed thanks to its accessibility on both sides and continues to meet the normative requirements for the accessibility of the emergency stop control.
All new devices with a UserTerminal Touch (Pro) are not affected, as they follow a different technical design.
Corrective measure:
For all 9 affected devices, we are providing our customers with a free conversion kit consisting of:
- 2x cos15933 emergency stop control element
- Adapter cable cos100770
- Service/assembly instructions: "Installation Guide Emergency Off Locomotion"
N:\article\cos30001-01\20260119_cos30001-01va02_Installation_Guide_Emergency_Off_Locomotion_signed.pdf
The conversion can be carried out by the customer themselves and has been deliberately kept simple: The existing emergency stop connection is reconnected using the new emergency stop controls (plug-and-play) – without interfering with the device software and without special tools. After reconnecting, a brief functional test must be carried out in accordance with the enclosed instructions and the implementation must be confirmed (see feedback).
Passing on Information: Please forward these safety instructions to all treadmill users in your facility.
Feedback: Please confirm that you have implemented the immediate measures by sending an email to: safety@hpcosmos.com
Contact: Christian Melcher, Head of Technical Customer Service, christian.melcher@hpcosmos.com / +49 8669 8642-25