On May 24, 2024, the NMPA released the latest medical device recall information, involving five products from four companies:
▲NMPA Screenshot
1、Medtronic: Mobile O-Arm X-Ray System
Medtronic (Shanghai) Management Co., Ltd. reported that due toAn electrical component of the imaging system may intermittently shut down, affecting system usage., produced by Medtronic Navigation, Inc. (Littleton)Mobile O-Arm X-Ray Machine(China Medical Device Registration No. 20183060139) Voluntary Recall. Recall Level isLevel 3 Recall。
2、Medtronic:Implantable Spinal Cord Neurostimulator
Medtronic (Shanghai) Management Co., Ltd. reported that due toCardioversion may damage electronic devices.For reasons such as ..., Medtronic Inc., the manufacturer, has taken action regarding its production.Implantable Spinal Cord Neurostimulator(Registration No. 20243120025 for Imported Medical Device) Voluntary Recall. Recall Level:Level 2 Recall。
3. InventoryK Company:Drainage CatheterCook (China) Medical Trading Co., Ltd. reported that due to the productIncorrect Expiry Date on Label, the manufacturer Cook Incorporated for its production ofDrainage Catheter(Registration No. 20192142121 for Medical Device Imported into China) Voluntary Recall. The recall level isLevel 2 Recall。
4、Philips Healthcare: Medical Magnetic Resonance Imaging SystemPhilips (China) Investment Co., Ltd. reported that due toThe system has software issues., produced by Philips Medical Systems Nederland B.V.Medical Magnetic Resonance Imaging System Magnetic Resonance Equipment(Registration No. 20153062757 for Medical Device Imported into China) Voluntary Recall. Recall Level isLevel 2.
5. Abbott: Controllable Catheter Sheath with Hemostatic ValveAbbott Medical Products (Shanghai) Co., Ltd. reported that due toThe dilator is too short to extend beyond the catheter sheath., manufactured by St. Jude Medical, for its production ofAgilis NxT Steerable Introducer with Hemostasis Valve（China Medical Device Registration No. 20153031169) Voluntary Recall. Recall Level isLevel 2 Recall。
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Editor-in-Chief | Zhao Qing Reviewed by | Yi He
