h/p/cosmos Issues Field Safety Notice: 9 Medical Treadmills Recalled for Emergency Stop Lanyard Failure Risk

Korrekturmasnahme FSCA
h/p/cosmos Field-Safety-Notice (FSN) / Korrekturmaßnahme (FSCA)

JANUARY 22, 2026 — Nussdorf-Traunstein, Germany — German medical rehabilitation equipment manufacturer h/p/cosmos sports & medical gmbh has issued a Field Safety Notice (FSN) and Field Safety Corrective Action (FSCA) affecting a small batch of locomotion-series medical treadmills. The magnetic pull-cord emergency stop function may fail to shut down the running belt reliably in an emergency.

The main mushroom-shaped emergency stop button on the handrails remains fully functional and unaffected. This corrective action covers 9 units and has been filed with and monitored by Germany’s Federal Institute for Drugs and Medical Devices (BfArM).

Affected Products & Scope

Product Models:

• locomotion 150/50 DE med — Item No. cos30001-01va02
• locomotion 190/65 DE med — Item No. cos30024va04

Classification:

Class IIb medical device, intended for gait therapy, physiotherapy, and diagnostic exercise applications. Compliant with EU Regulation 2017/745 (MDR).
Production Date: Units manufactured from February 2025 onward equipped with the older MCU5 user terminal. Newer units with the UserTerminal Touch (Pro) are unaffected.

Quantity:

9 units total — identified by serial numbers:
cos30001-01va02-0135, -0136, -0137, -0138, -0139, -0140, -0141, -0142; cos30024va04-0005

Distribution:

Deployed in Austria, Spain, Germany, United Kingdom, Ukraine, and Morocco.

Hazard Description

The safety pull-cord is a required emergency-stop trigger per DIN EN ISO 20957-6. Following a component change on this specific production batch, the actuation current threshold was set too high, causing the magnetic pull-cord switch to occasionally fail to trigger a stop when pulled.

One clinical user reported that pulling the lanyard during patient therapy did not stop the belt; the treadmill was halted only by pressing the handrail-mounted mushroom emergency stop button. Internal review confirmed that on these 9 units, the pull-cord emergency stop cannot be guaranteed to function reliably in every instance.

Important Clarification: The handrail-mounted mushroom-button emergency stop operates independently and remains fully functional at all times. Only the magnetic pull-cord is affected.

Risk Assessment

If the pull-cord fails to stop the belt during an emergency, shutdown response time may be delayed until the secondary emergency stop is activated. This increases the risk of:

• Slips, falls, and loss of balance, potentially causing abrasions, bruises, sprains, and in severe cases, fractures or head injuries
• Higher risk for patients with limited mobility, where delayed stopping may have more serious consequences
• Injury risk to attending staff or bystanders reacting to an unexpected situation

⚠️ Critical Note: The pull-cord is not a fall-prevention system. It is designed to stop the belt — it cannot prevent a fall. Reliance solely on the lanyard for safety creates a false sense of security. Patients at elevated fall risk require physical safety handrails or fall-protection frames regardless of lanyard function.

Immediate Interim Measures (Until Retrofit)

1. Verify serial number — Check if your unit is listed above.
2. Continuous supervision required — The treadmill must only be used when a trained attendant is present and within immediate reach of the handrail emergency stop button.
3. Pre-test before every use — Test both the pull-cord AND the mushroom-button emergency stop before each session.
4. Mandatory fall protection — For gait therapy or patients with balance impairment, use dedicated safety handrails or fall-protection frames.
5. Immediate removal from service — If either emergency stop fails to operate instantly, or if continuous supervision cannot be ensured, discontinue use until retrofitted.

Corrective Action: Free Retrofit Kit — Dual Emergency-Stop Buttons

To eliminate the risk entirely, h/p/cosmos will replace the pull-cord system with two mushroom-button emergency stops — one on the left handrail, one on the right. This design provides redundant, intuitive emergency access from both sides, fully satisfies DIN EN ISO 20957-6 reachability requirements, and eliminates reliance on the magnetic lanyard.

Retrofit Kit Provided at No Cost Includes:

• 2× Mushroom-head emergency stop assemblies (cos15933)
• Adapter cable (cos100770)
• Step-by-step installation guide

Installation: Plug-and-play design — no software modification, no special tools required. Simply swap the existing connector per instructions, perform a brief function test, and confirm completion via email.

Confirmation Required: After completing the retrofit, submit the confirmation form within 14 calendar days to safety@hpcosmos.com so the manufacturer can document and verify full compliance.

Regulatory & Contact Information

• Manufacturer: h/p/cosmos sports & medical gmbh, Am Sportplatz 8, 83365 Nussdorf-Traunstein, Germany
• BfArM Vigilance Report No.: 03065/26 — Filed January 22, 2026
• Reference: VF2026-0003
• Technical Support: Christian Melcher, Head of Technical Customer Service — +49 8669 8642-25 | safety@hpcosmos.com
• Full Notice & Serial Number List: https://www.hpcosmos.com/de/sicherheit

Disclaimer: This article summarizes the official Field Safety Notice published January 22, 2026. Always verify against the manufacturer’s official notice and confirm your unit’s serial number before taking action.


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Infomation Source: BFARM.DE

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