14 multinational machinery companies recalled products in China, GPS, BD, Johnson & Johnson, Roche, Medtronic...

Release date: 2016-10-18

On October 12, the Shanghai Food and Drug Administration issued 23 reports of medical device recalls.

The above 23 recalls are all “active recalls” and almost all recalled products are produced or sold in China. Among them, including one I-level recall, 10 second-level recalls, and 12 third-level recalls. Cypress Blue believes that recall is a responsible attitude.

They are as follows:

1. Mai Kewei: Mobile operating table

Mai Kewei (Shanghai) Medical Equipment Co., Ltd. reported that the company found that the poor square welding may cause damage between the square hole of the operating room accessory adapter and the first joint, which may cause serious injury to the patient. The company decided to recall the relevant products, this recall level II.

Areas and countries involved: global.

The number of sales in China: 62 units.

2, Mai Ke Wei: medical physical temperature meter and artificial heart-lung machine - heat exchange water tank

Mai Kewei (Shanghai) Medical Equipment Co., Ltd. reported that the company found mycobacterial contamination (and other bacterial contamination) in the water of the artificial heart-lung machine-heat exchange water tank. The company decided to recall the product and notify relevant customers to take corrective measures. And the timing of the release of the new disinfection process by the manufacturer. This recall level is Level III.

Areas and countries involved: global.

The number of sales in China: 418 units.

3, Bangmei: modular full knee system

Bangmei (Shanghai) Trading Co., Ltd. report: The company survey found that the drill bit used for the hexagonal hole drilling of the bolt head may be larger than the acceptable allowable value of the tolerance, which may result in the bolt not being fully tightened. The company decided to recall the relevant products, this recall level II.

Regions and countries involved: the United States, Europe, the Middle East and the Asia Pacific region.

The number of products involved in production (or importing China): 159 pieces.

Number of sales in China: 0 pieces.

4, GE: baby warmth

General Electric Medical Systems Trade Development (Shanghai) Co., Ltd. report: The company found that the screws involved in the heating part of the product are at risk of loosening. If the radiant heating part is not properly maintained, the hot screws may fall onto the mattress and contact. There are risks to the patient. The company decided to recall the relevant products, this recall level II.

Areas and countries involved: the United States, Australia, Canada, China and other countries and regions.

Sales in China: 254.

5. GE: Magnetic Resonance Imaging System

General Electric Medical Systems Trade Development (Shanghai) Co., Ltd. Report: The company received a recall notice from the CADStream component supplier, and the product SureLoc function and PURE function are defective. The company decided to recall the relevant products, this recall level II.

Areas and countries involved: Australia, China and other countries and regions.

Number of sales in China: 34.

6, Medtronic: argon-enhanced electrosurgical system, electrosurgical instruments

Medtronic (Shanghai) Management Co., Ltd. reported that the company found that there were seal defects in the inner packaging of the product, and there was a possibility that the sterile barrier was destroyed, which increased the risk of infection. The company decided to recall the relevant products and recycle all unused products. This recall level is Level II.

Areas and countries involved: global.

The number of sales in China: 103 boxes.

7, Medtronic: Plasma Surgery System

Medtronic (Shanghai) Management Co., Ltd. report: The company's internal tests found that individual products could not pass the electromagnetic compatibility test. The company decided to recall the relevant products. The recall level is Level III.

Areas and countries involved: China.

The number of sales in China: 80 units.

8, Medtronic: mobile C-arm X-ray machine

Medtronic (Shanghai) Management Co., Ltd. reported that the company found that some of the technical information in the user manual related to the product did not meet the requirements of US regulations; secondly, the production and maintenance documents of the affected product did not comply with US regulations. In addition, there may be a risk of damage due to improper packaging. The company decided to recall the relevant products. The recall level is Level II.

Areas and countries involved: global.

The number of sales in China: 19 units.

9, Medtronic: microelectrode driver

Medtronic (Shanghai) Management Co., Ltd. Report: The company found that the date of manufacture of the product involved did not meet the regulatory requirements before the date of approval of the product registration certificate. The company decided to recall the relevant products. This recall level is Level III.

Areas and countries involved: China.

Number of sales in China: 83 pieces.

10, Kaijie: high-risk human papillomavirus test kit

Kaijie Enterprise Management (Shanghai) Co., Ltd. report: The company found that the product labeling products are valid for more than 12 months and the product registration period is 12 months, which is inconsistent with Chinese regulations. The company decided to recall the relevant products, this recall level III.

Areas and countries involved: China.

The number of sales in China: 1,964 boxes.

11. Siemens: Digital Medical X-ray System

Shanghai Siemens Medical Co., Ltd. report: The company found that the bed components involved in the product may cause the patient on the bed to slip because the missing limit ring is missing during the production process. The company decided to recall the relevant products. This recall level is Level III.

Areas and countries involved: China.

The number of sales in China: 8 units.

12, Siemens: automatic biochemical analyzer

Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. report: The company found that there are problems with the product software. The company decided to recall the relevant products, this recall level III.

Areas and countries involved: China.

The number of sales in China: 19 units.

13, Roche: vancomycin test kit

Roche Diagnostics (Shanghai) Co., Ltd. Report: The company found that the product description is incorrectly described in terms of the detection of the reagent on its applicable model and the method of COBASINTEGRA detection in the fully automated biochemical analysis system. The company decided to recall the relevant products and update the relevant description of the methodological comparison in the product manual. This recall level is Level III.

Areas and countries involved: global.

The number of sales in China: 59 boxes.

14, Roche: blood gas, electrolytes, biochemical calibrators

Roche Diagnostics (Shanghai) Co., Ltd. report: The company found that the use of batch-related products may cause errors in the calibration of oxygen partial pressure parameters. The company decided to recall the relevant products, this recall level II.

Areas and countries involved: global.

The number of sales in China: 925 boxes.

15, Terumo: vascular stent

Terumo Medical Products (Shanghai) Co., Ltd. report: The company's production inspection found that during the assembly of the bracket and the delivery system, the pressure exerted on the bracket may cause slight deformation of the bracket, which may cause the bracket itself to not fully expand and cause the bracket The diameter of both ends is reduced or the bracket is deformed. The company decided to recall the relevant products. The recall level is Level II.

Areas and countries involved: global.

The number of products involved in production (or imports from China): 125.

The number of sales in China: 0.

16, Philips: patient monitor

Philips (China) Investment Co., Ltd. reports: If the monitor has been powered on for several months without being turned off or restarted, the monitor may exhibit a waveform lag that does not reflect the patient's immediate condition. The company decided to recall the relevant products. The recall level is Level II.

Areas and countries involved: global.

The number of sales in China: 939 units.

17, BD: sample preservation solution

Report from BD Medical Devices (Shanghai) Co., Ltd.: A company survey found that cracks may occur in a small number of caps involved in the product, which may cause leakage of the preservation solution. The company decided to recall the relevant products, this recall level III.

Areas and countries involved: the United States, etc.

Sales in China: 2,751,000 bottles.

18, BD: leukocyte differentiation antigen CD3/CD4/CD45 detection kit

Report by BD Medical Devices (Shanghai) Co., Ltd.: The company survey found that the words “gelatin” were incorrectly marked on the label of the English bottle involved in the product, and the actual “labeled buffer” should be marked. The company decided to recall the relevant products, this recall level III.

Areas and countries involved: global.

The number of sales in China: 1,510 boxes.

19. Johnson & Johnson: Power System

Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd. reported that the company found that the affected connecting cable may generate excessive internal pressure and explode, which may cause harm to users and patients. The company decided to recall the relevant products, this level of recall level I.

Areas and countries involved: global.

Number of sales in China: 20 pieces.

20. Johnson & Johnson: Total Knee Replacement System

Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd. Report: The company found that the affected products of a specific model-specific batch number were incorrectly added with the Chinese manual of other products under the same registration certificate. The company decided to recall the relevant products, this recall level III.

Areas and countries involved: China.

Sales in China: 411 pieces.

21. Tosoh: Contains alkaline phosphatase series detection reagents

Tosoh (Shanghai) Biotechnology Co., Ltd. report: The company found that the use of alkaline phosphatase series detection reagents in the determination of patients receiving low alkaline phosphatase treatment samples will lead to false high values ​​in the sandwich method test results. The results of the competition law project have a false low value. The company decided to recall the relevant products, this recall level III.

Areas and countries involved: global.

Sales in China: All AIA customers.

22, Mérieux: nucleic acid extraction reagent

Mérieux Diagnostics (Shanghai) Co., Ltd. Report: Corporate headquarters received complaints, using the nucleic acid extracted by Mérieux instrument for amplification performance problems when performing user-defined downstream PCR and RT-PCR experiments; The cassette has an effect on the double-strand accounting with an extraction volume greater than 400 ul. The company decided to recall the relevant products, this recall level III.

Areas and countries involved: global.

The number of sales in China: 67 boxes.

23, Fuji: Digital Mammography X-ray Diagnosis System

Fujifilm (China) Investment Co., Ltd. reports: In the process of stereoscopic puncture exposure, the C-arm rotates between 3.0 and 3.3 seconds, releasing the exposure switch, the system software may report an error, the exposure cannot continue, and it cannot be recovered automatically or manually. . The company decided to recall the relevant products. The recall level is Level II.

Areas and countries involved: global.

Sales in China: 4 units.

Source: Shanghai Food and Drug Administration cypress blue equipment finishing

Double Door Safe Box

Double Door Safe Box,Home Safe Box,Ammunition Safe Box,Gun Safe

Hebei Tiger Brand Group Jia Bao Cabinet Industry Co. LTD , https://www.cntigersafe.com