Medical network May 10 - on May 8, the Shanghai food and drug administration 31 one-time released for medical equipment company is voluntarily recalling information, this recall involves four level of recall. 

 

It is worth noting that the Shanghai bureau of drug administration has made a special post on the official website. 

 

, to strengthen the regulation of medical device recall, the measures for the administration of medical device recall was carried out this year, this approach has been clear about the medical device manufacturing enterprise is its product quality and safety responsibility main body, shall, in accordance with the measures to establish and perfect the system of medical device recall management, medical equipment safety related information collection, to investigate the possible defects in the product, assessment, defect product recall in a timely manner. 

 

The article also submitted to the medical device business enterprise, the use unit to the relevant product recall to cooperate. 

 

The Shanghai bureau of drug administration had issued the recall information for medical devices, but it was not the same. This shows the importance of the implementation of the management measures for medical devices. 

 

Similarly, jiangxi food and drug administration in the latest flight test results reported, also specially emphasized, proper oversight the unqualified products, related to the medical device production enterprise shall timely recall, and notify the enterprise and the use of units. 

 

In conjunction with the announcement of the state administration of drug administration on the eve of May Day, the new regulations on the recall of medical equipment are required. It is clear that the formal implementation of the medical device recall administration measures has already begun to take effect. 

 

The following is the latest list of 31 recalled information released by the Shanghai administration of drug administration: 

 

Philips (China) investment co., LTD. Has voluntarily recalled the monitor defibrillator 

 

Philips (China) investment co., LTD. Offers a voluntary recall of X-ray computerized tomographic equipment 

 

Philips (China) investment co., LTD. Offers an active recall of angiographic X-ray system and angiographic X-ray system 

 

Philips (China) investment co., LTD. Of single photon emission computed tomography (ct) system of single photon emission and X-ray computed tomography (ct) imaging system is voluntarily recalling 

 

The Olympus trade (Shanghai) co., LTD. Has voluntarily recalled the electronic duodenal mirror 

 

Olympus trade (Shanghai) co., LTD. Is voluntarily recalling electronic chest laparoscopy 

 

Olympus trade (Shanghai) co., LTD. Has voluntarily recalled the high frequency removal electrode 

 

Medtronic (Shanghai) management co., LTD. Offers an active recall of implantable neural stimulation electrodes 

 

Medtronic (Shanghai) management co., LTD. Is voluntarily recalling the program 

 

Medtronic (Shanghai) management co., LTD. Has voluntarily recalled the laminated scaffold system 

 

Johnson &johnson (Shanghai) medical equipment co., LTD. Is actively recalling the bidirectional guide scabbard 

 

Johnson &johnson (Shanghai) medical equipment co., LTD. Is actively recalling the cavity mirror and the straight line cut 

 

Doctor ren (Shanghai) trading co., LTD. Has voluntarily recalled the operation of an ophthalmic operation 

 

Beckman coulter trade (China) co., LTD. Is voluntarily recalling the automatic immune analyzer 

 

Beckmankurt commerce (China) co., LTD. Has voluntarily recalled the immunoglobulin G test kits 

 

Bellang medical (Shanghai) international trading co., LTD. Has voluntarily recalled the power system tools 

 

Bellang medical (Shanghai) international trading co., LTD. Has voluntarily recalled the reconstruction of the anterior cruciate ligament 

 

Bole life medical products (Shanghai) co., LTD. Offers a voluntary recall of hemoglobin a1c 

 

Bole life medical products (Shanghai) co., LTD. Offers an active recall of irregular antibody screening with red blood cell test kits/human ABO blood type 

 

Ge medical systems trade development (Shanghai) co., LTD. Is actively recalling the magnetic resonance imaging system 

 

Orson medical device trade (China) co., LTD. Offers an active recall of n-terminal sodium peptide determination reagents 

 

Solin medical (Shanghai) co., LTD. Has voluntarily recalled the defibrillator, implantable defibrillator, defibrillator and defibrillator 

 

Sonling diagnostic medical equipment (Shanghai) co., LTD. Has voluntarily recalled the determination of C peptide 

 

Xerox medical products international trade (Shanghai) co., LTD. Has voluntarily recalled all hip replacement surgery manual tools 

 

Reeko asia-pacific investment management (Shanghai) co., LTD. Is a digital medical X-ray camera system. Digital mobile photography X-ray machine initiative recalls 

 

Perkin Elmer medical diagnostic products (Shanghai) co., LTD (Shanghai) co., LTD. Offers a voluntary recall of phenylalanine test kits (fluorescent) 

 

Spas aerospace medical instruments (Shanghai) co., LTD. Offers an active recall of the anesthetic system 

 

Abbott medical devices (Shanghai) co., LTD. (Shanghai) co., LTD. (Shanghai) co., LTD. (Shanghai) co., LTD. (Shanghai) co., LTD. (Shanghai) co., LTD. (Shanghai) co., LTD. (Shanghai) co., LTD. (Shanghai 

 

Semerfly technology (China) co., LTD. Is voluntarily recalling the cleaning fluid 

 

100 medical supplies trade (Shanghai) co., LTD. Is voluntarily recalling the continuous blood purification equipment 

 

Jemay (Shanghai) medical international trading co., LTD. Offers a voluntary recall of knee joint components 

 

Among them, the highest level of product defect recall 4, including: 

 

1, philips (China) investment co., LTD., is voluntarily recalling guardianship defibrillator reason: the defect of the power components, may lead to equipment can't work normally; 

 

2, medtronic (Shanghai) management co., LTD., is voluntarily recalling program-controlled apparatus, in July 2013 to follow up the corrective action. The purpose is by updating the model software for 8870 card and drug perfusion system on initial large doses of the filling, use the tag reduce abnormal dosing cause clinical drug perfusion system the risk of adverse events, so as to solve the problem of abnormal drug delivery; 

 

3, sorin medical (Shanghai) co., LTD., is voluntarily recalling: is the cause of implantable cardioerter defibrillator heart defibrillation lead failure caused by instrument awareness, make the defibrillation shock capacitance charging repeatedly, lead to the depletion of battery cannot be identified; 

 

4, abbott medical devices trading (Shanghai) co., LTD., is voluntarily recalling coronary artery catheter balloon expansion reason: the particular batch products may be difficult to remove the balloon protection sheath, which may lead to a balloon filling or shrink.