Medtronic Issues Class I Recall in China for Surgical Navigation Systems Due to Software Defect
Medtronic
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Medtronic (Shanghai) Management Co., Ltd. reported,Due to software anomalies, errors in the biopsy needle's depth limit setting may occur, among other reasons.Medtronic Navigation, Inc., the manufacturer, has voluntarily recalled its Cranial Treatment Guidance System (Registration No. 20183010514), Spine Treatment Guidance System (Registration No. 20183010510), and ENT Treatment Guidance System (Registration No. 20183010507) used for neurosurgery, spinal surgery, and ENT surgery respectively. The recall level is Class I.
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