China NMPA Product Recall - Wavefront aberrometer; femtosecond laser treatment machine for ophthalmology

Allergan (Shanghai) Medical Devices Trading Co., Ltd. initiated a voluntary Class III recall of its wavefront aberration analyzers and femtosecond laser treatment machines for ophthalmology, as reported by the Shanghai Municipal Drug Administration on November 2, 2021. The proactive recall addresses a critical vulnerability in the Microsoft Windows Print Spooler function, which is utilized by the affected medical devices. This software flaw could potentially allow a malicious attacker to gain unauthorized full access and control over the system, particularly for devices connected to a network. Although Allergan had not received any complaints or reports of this vulnerability being exploited, the company acted promptly to ensure product quality and patient safety. The affected products include those with Registration Certificate Nos. 20153160177 and 20213160021. This action falls under the regulatory oversight of the Shanghai Municipal Drug Administration, a regional body of the National Medical Products Administration (NMPA). Further specific details regarding the models, specifications, and batches of the recalled medical devices are provided in the accompanying "Medical Device Recall Event Report Form". The recall emphasizes the company's commitment to mitigating potential risks despite the absence of reported incidents.