Medical network on March 23 - March 17, the Shanghai municipal food and drug administration announced 15 medical equipment product is voluntarily recalling, related products are imported or sales in China.
Are:
1, medtronic (Shanghai) management co., LTD of cerebrospinal fluid shunt pipe and accessories, lumbosacral peritoneal shunt pipe component is voluntarily recalling
Registration certificate number: China machinery note in 20143665605, the food YaoXie (into) the 2014 no. 3661857
Recall levels: level III
Recall the reason: the company, the survey found in very rare cases, the accumulation of biological debris inside the pressure regulating valve can restrict the free rotating magnet in the valve, when exposed to 3.0 tesla MRI, regulating mechanism may lead to damage.
More than 2, orson medical equipment trade (China) co., LTD., the determination of lithium dry (colorimetry) is voluntarily recalling
Registration certificate number: the machinery in 20152402801
The level of recall: class II
Recall the reason: companies are discovering that using two batch determination of lithium dry bias may result in intermittent.
More than 3, orson medical equipment trade (China) co., LTD. Determination of calcium slice (colorimetry) is voluntarily recalling
Registration certificate number: the machinery in 20152402836
Recall levels: level I
Recall the reason: the batch number part of the product packaging in China, error with alanine aminotransferase determination of dry slice method (rate) of Chinese label.
4, drager medical equipment (Shanghai) co., LTD., the active recall breathing machine/breathing treatment system
Registration certificate number: the machinery in 20163541851, national machinery injection into 20153543551, the food machinery (into) the word no. 3540423 2014
Recall levels: level I
Recall the reason: in February 2016 start breathing machine, breathing treatment system matching PS500 auxiliary power supply after the recall, battery defects still need further perfect.
5, beckman coulter commerce (China) co., LTD. Chemical analysis system of automatic urine is voluntarily recalling
Registration certificate number: the machinery in 20172400126
Recall levels: level III
Sample product recall reasons: the enterprise discovery needle position is incorrect, or bending may cause chemical dipsticks point sample amount is insufficient, affect the test result.
6, wave international medical trading (Shanghai) co., LTD., is voluntarily recalling the thrombus suction control systems
Registration certificate number: the machinery in 20153773552
Recall levels: level III
Foot switch product recall reason: in the process of using stuck causing unintended continuous work.
7, sorin medical (Shanghai) co., LTD., is voluntarily recalling in heat exchange water tank system
Registration certificate number: feed the drug safety machinery (into) the word no. 2454894 2013 (more)
The level of recall: class II
Recall the reason: since U.S. regulators about heat exchange water tank system using bacillus tuberculosis conflict in the process of announcement.
8 minimally invasive orthopedic medical technology co., LTD., Shanghai instrument set is voluntarily recalling to hip surgery
Product recall reasons: the company found that bone file can not be normal lock on the handle, forcibly lock bone file after bone file and properly handle.
9, abbott medical equipment trading (Shanghai) co., LTD., is voluntarily recalling in vascular closure system
The registration certificate number: countries food drug safety machinery (into) the word no. 3461585 2013
The level of recall: class II
Product recall reasons: the company found possible closure clip release difficult or unable to release.
10, philips (China) investment co., LTD. Of single photon emission computed tomography (ct) scanning system, single photon emission and X-ray computed tomography (ct) imaging system is voluntarily recalling
Registration certificate number: CFDA (I) 20143331168
The level of recall: class II
Product recall reasons: the company found the following problems, a motion controller is warning information, the system may stop; Second, X-ray scanning, door lock device switch fault; 3 it is to uninstall the patients, the probe contact Joe. Four is gating plane scan, JETSream binding.
11, perkin Elmer medical diagnostic products (Shanghai) co., LTD., is immune to automatic fluorescent analyzer is voluntarily recalling
Registration certificate number: the machinery in 20143405992
The level of recall: class II
Recall the reason: the company found that some of the product defect of sliding bearing, long-term exposure to corrode in damp environment risk, once the sliding bearing is corrosion, may affect the test results.
12, perkin Elmer medical diagnostic products (Shanghai) co., LTD of AFP determination kit (time-resolved fluorescence) is voluntarily recalling
Registration certificate number: the machinery in 20142405379
Recall levels: level III
Recall the reason: the survey found that involves batch product of test pen barcode printing defects, affect the normal test products.
13, Kang Disi (Shanghai) medical equipment co., LTD., is voluntarily recalling in niti stent system
Registration certificate number: the machinery in 20163460050
The level of recall: class II
Recall reasons: the company found that part of the product release difficulties, release the failure phenomenon.
14, di medical equipment (Shanghai) co., LTD for the arterial blood collector is voluntarily recalling
Registration certificate number: the machinery in 20153150005
The level of recall: class II
Product recall reasons: the company found in front of the cover lock when you hear "cut" guard may not fully locked.
15, Kang Erfu sheng (Shanghai) trading co., LTD., is voluntarily recalling of bone marrow biopsy needle
Registration certificate number: feed the drug safety machinery (into) the word no. 3152848 2013 (more)
The level of recall: class II
Recall the reason: the company found that involves the product aseptic packaging defects, can guarantee the product aseptic, local or systemic infection may lead to the user. |
