Urgent Field Safety Notice For Ecg Mobile By Suzhou Beneware Medical Equipment Co., Ltd

Recall Summary Suzhou Beneware Medical Equipment Co., Ltd is issuing an urgent field safety notice for ECG Mobile devices distributed in Germany and the EU. The notice addresses an identified risk related to the device's operation. This is classified as a Class I recall, indicating a serious safety concern affecting the product.

Recalling firm

Urgent Field Safety Notice for ECG Mobile by Suzhou Beneware Medical Equipment Co., Ltd , Download_VeroeffentlichtAm_EN

Product

s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for ECG Mobile by Suzhou Beneware Medical Equipment Co

Reason

assessment Field corrective actions Urgent Field Safety Notice for ECG Mobile by Suzhou Beneware Medical Equipment Co

Classification

Class I

Category

medical device recall

Country

Germany

Agency

BFARM

Recall date

2026-05-06

Status

Ongoing

Distribution

Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/ca879cbd-ffd7-4ae6-a9a3-5e7cfeb73cd7