NMPA Announces Recall of Multiple Medical Devices by Philips, Medtronic, and Others
Aug 04, 2022 14:14
CST Updated
14:14
Medtronic
Chronic Disease Medical Device and Therapy Developer
Philips
Philips Medical (Suzhou) Co., Ltd. reported thatEnterpriseAfter the device restarts, it was found that the image display direction is incorrect after checking the position switch. A voluntary recall is now being initiated, with a recall level of two.
Medtronic
Medtronic (Shanghai) Management Co., Ltd. reported that due to the issue of clamp tip breakage, the registrant, Medtronic, Inc., initiated a voluntary recall of The Accessories of Cardioblate Surgical Ablation System (Registration Certificate No.: Guo Xi Zhi Jin 20173011933, Original Registration Certificate No.: Guo Xi Zhi Jin 20173251933). The recall level is Class I.
Guanlong Medical
Shandong Guanlong Medical Products Co., Ltd. reported that due to the discovery of non-conforming red, green, and blue light flux ratios during sampling inspections, the company has proactively recalled its medical cold light source products. The recall level is classified as Level Three.
Edan Instruments
Shenzhen Edan Instruments, Inc. is voluntarily recalling its IBP Cable (B.Braun connector) for patient monitors, with model numbers 01.57.471835012, 01.57.471835013, and 01.57.471836013. The recall level is Class III.
Beaojiyin
Guangzhou BioGene Biotechnology Co., Ltd. voluntarily recalls its disposable medical protective clothing with the production batch number 2020120101. The recall level is Class III.
KunAo Medical
Shandong Kunao Technology Medical Co., Ltd. reported that due to inadequate production protection and other reasons, the company is voluntarily recalling its disposable samplers. The recall level is Class III.
Philips
Philips Medical (Suzhou) Co., Ltd. reported thatEnterpriseAfter the device restarts, it was found that the image display direction may be incorrect after checking the position switch. A proactive recall is now being conducted, with a recall level of Level 2.
Medtronic
Medtronic (Shanghai) Management Co., Ltd. reported that due to the issue of clamp tip breakage, the registrant Medtronic, Inc. initiated a voluntary recall of The Accessories of Cardioblate Surgical Ablation System (Registration Certificate No.: Guo Xi Zhi Jin 20173011933, Original Registration Certificate No.: Guo Xi Zhi Jin 20173251933). The recall level is Class I.
Guanlong Medical
Shandong Guanlong Medical Products Co., Ltd. reported that due to reasons such as the red, green, and blue light auxiliary flux ratio not meeting requirements during random inspections, the company is voluntarily recalling its medical cold light source products. The recall level is classified as Level Three.
Edan Instruments
Shenzhen Edan Instruments, Inc. is voluntarily recalling its IBP Cable (B.Braun connector) for patient monitors, with model numbers 01.57.471835012, 01.57.471835013, and 01.57.471836013. The recall is classified as Class III.
Beaojiyin
Guangzhou BioGene Biotechnology Co., Ltd. voluntarily recalls its disposable medical protective clothing with the production batch number 2020120101. The recall level is Class III.
KunAo Medical
Shandong Kunao Technology Medical Co., Ltd. reported that due to inadequate production protection and other reasons, the company is voluntarily recalling its disposable samplers. The recall level is Level III.