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Class 2 Device Recall Medfusion Syringe Pump

2017-11-13  Class 2 Device Recall Medfusion Syringe Pump: Date Initiated by Firm: November 13, 2017: Date Posted: March 05, 2018: Recall Status 1: Open 3, Classified: Recall Number: Z-1134-2018: Recall Event ID: 78922: ... for Recall: Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication ...

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Class 2 Device Recall Medfusion Syringe Pump

2017-11-13  Class 2 Device Recall Medfusion Syringe Pump. The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes ...

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Class 2 Device Recall MEDFUSION SYRINGE INFUSION

2010-6-22  Manufacturer. Smiths Medical ASD, Inc. 1265 Grey Fox Rd. Saint Paul MN 55112-6929. For Additional Information Contact. 651-628-7280. Manufacturer Reason. for Recall. Smiths Medical is conducting a correction of Medfusion¿ Syringe Infusion Pumps, Models 3010 and 3010a, with obsolete software versions 2.0.2, 2.0.3, and 2.0.4.

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Class 2 Device Recall Medfusion Syringe Infusion Pump

2008-12-18  A small, lightweight and portable syringe infusion pump. The Medfusion 3500 syringe pump is indicated for use with the following delivery routes: Arterial, Epidural, Enteral, Intravenous, Spinal, Subcutaneous for delivering the following fluids: Intravenous solutions, drug Solutions, blood or blood products and enteral feedings. Code Information.

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Class 2 Device Recall Medfusion Syringe Pump, 3500 Series

Minneapolis MN 55442-1690. For Additional Information Contact. Technical Service. 800-258-5361. Manufacturer Reason. for Recall. Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the "Invalid Syringe Size" alarm.

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Class 2 Device Recall Medfusion Syringe Infusion Pump,

2015-12-3  26. - Product Code FRN. 27. Product. Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728. Code

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Class 2 Device Recall Medfusion 3500 V5 Syringe Pumps

2022-7-14  Product. Smiths Medical, Medfusion¿ 3500 Syringe Pumps, Software version 5.0.0, Rx Only. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood or blood products, and enteral feedings in continuous, intermittent, and body weight delivery modes. Code Information.

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Class 2 Device Recall Medfusion 4000 Syringe Infusion

2013-11-22  Smiths Medical ASD, Inc. 1265 Grey Fox Rd. Saint Paul MN 55112-6929. For Additional Information Contact. 651-633-2556. Manufacturer Reason. for Recall. Smiths Medical is conducting a recall involving all Medfusion¿ 4000 Syringe Infusion Pumps. Smiths Medical has identified an issue with electrical shorting at the AC power receptacle.

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Recall of Device Recall Medfusion Syringe Pump

Recall of Device Recall Medfusion Syringe Pump ... Event Risk Class Class 2 Event Number Z-1134-2018 Event Initiated Date 2017-11-13 Event Date Posted 2018-03-05 ... Certain medfusion syringe pump models, series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. the inability of a pump to recognize a syringe ...

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URGENT MEDICAL DEVICE CORRECTION

2022-4-20  Medfusion™ 3500 and 4000 Syringe Infusion Pumps . April 19, 2022: Dear Valued Medfusion Customers : Director of Biomedical Engineering Director of Nursing Director of Risk Management Smiths Medical is issuing this letter to notify you of potential issues with the Medfusion eight Syringe Infusion Pump.

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Recall of Device Recall Medfusion Syringe Pump

Recall of Device Recall Medfusion Syringe Pump ... Event Risk Class Class 2 Event Number Z-1134-2018 Event Initiated Date 2017-11-13 Event Date Posted 2018-03-05 ... Certain medfusion syringe pump models, series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. the inability of a pump to recognize a syringe ...

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Recall of Device Recall Medfusion Syringe Infusion Pump

Recall of Device Recall Medfusion Syringe Infusion Pump ... Class 2 Event Number Z-1018-2009 Event Initiated Date 2008-12-18 ... Delay in therapy. keypad issues with medfusion syringe infusion pump, model numbers 3500-306 and 3500-415 ("pump") have occurred during implementation or shortly after first being placed into use. ...

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Recall of Device Recall Medfusion Syringe Pump, 3500 Series

Recall of Device Recall Medfusion Syringe Pump, 3500 Series ... Class 2 Event Number Z-0314-2018 Event Initiated Date 2017-08-22 ... Pump, infusion - Product Code FRN. Reason Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to ...

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Device Recall Medfusion Syringe Pump

Device Recall Medfusion Syringe Pump Model / Serial Product Codes: 4000-0101-50, 4000-0101-51, 4000-0105-50, 4000-0105-51, 4000-0150-78, 4000-0106-00, 4000-0106-01 Product Classification General Hospital and Personal Use Devices Device Class 2

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Recall of Device Recall MEDFUSION SYRINGE INFUSION

Smiths medical is conducting a correction of medfusion¿ syringe infusion pumps, models 3010 and 3010a, with obsolete software versions 2.0.2, 2.0.3, and 2.0.4. smiths medical has found that pumps with obsolete software may continue to run past the set volume limit. this can result in an over-delivery if the syringe is over-filled. smiths ...

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UPDATED URGENT MEDICAL DEVICE RECALL NOTICE

2020-8-19  Recall Coordinator, Biomedical Department, Pharmacy . Affected Devices: Only Medfusion® 3500 and 4000 syringe pumps with the following Firmware Versions are within scope of this notice: Affected Model Affected Firmware Version Medfusion® 3500 6.0.0 Medfusion® 4000 1.5.0, 1.5.1, 1.6.0, 1.6.1, 1.7.0

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Medfusion 3500 and 4000 Syringe Pumps: Class I Medical

2020-8-26  On 26-Jun-2020, Smiths Medical sent an Urgent Medical Device Recall notice to all affected customers with the below instructions: To locate all devices- “Medfusion® 3500 and 4000 Syringe Pumps” in possession and verify the firmware version to determine if the pump is impacted by this notice.

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Smiths Medical recalls Medfusion 4000 due to

2019-12-19  Smiths Medical has recalled its Medfusion 4000 syringe pump with Firmware version 1.7.0 due to malfunctioning alarms and potential interruption of therapy, FDA said today. The FDA has labeled the ...

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2020 Medical Device Recalls FDA

2021-10-5  Tytek Medical Recalls TM-317 PneumoDart-Pneumothorax Needle Due to Fully and Partially Blocked Needles. 02/25/20. Abbott Vascular Recalls NC Trek RX and NC Traveler RX Coronary Dilatation ...

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FDA Issues Class I Recall Of Syringe Pumps Due To

2020-1-15  The FDA has issued a Class I recall of certain Medfusion® 4000 Syringe Pumps with Firmware Version 1.7.0 manufactured by Smiths Medical ASD, Inc. because the firmware could potentially cause the low battery alarms to stop working. ... Class I recall is the most serious type of recall: use of these devices may cause serious injuries or death ...

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Recall of Device Recall Medfusion Syringe Infusion Pump

Recall of Device Recall Medfusion Syringe Infusion Pump ... Class 2 Event Number Z-1018-2009 Event Initiated Date 2008-12-18 ... Delay in therapy. keypad issues with medfusion syringe infusion pump, model numbers 3500-306 and 3500-415 ("pump") have occurred during implementation or shortly after first being placed into use. ...

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Recall of Device Recall Medfusion Syringe Infusion Pump

Recall of Device Recall Medfusion Syringe Infusion Pump ... Class 2 Event Number Z-1019-2009 Event Initiated Date 2008-12-18 ... Delay in therapy. keypad issues with medfusion syringe infusion pump, model numbers 3500-306 and 3500-415 ("pump") have occurred during implementation or shortly after first being placed into use. ...

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Recall of Device Recall Medfusion Model 3500 Syringe Pump

Recall of Device Recall Medfusion Model 3500 Syringe Pump ... Class 2 Event Number Z-0996-2013 Event Initiated Date 2010-05-14 Event Date Posted 2013-03-26 ... Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates

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Device Recall Medfusion Syringe Pump, 3500 Series

Device Recall Medfusion Syringe Pump, 3500 Series Model / Serial Model No. 3500; Reference No. 3500-0600-51 Product Classification General Hospital and Personal Use Devices Device Class 2 Implanted device? No Distribution Worldwide Distribution: US (Nationwide) and countries of: Canada, Great Britain, Panama, Germany, India, Philippines, and ...

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Recall of Device Recall MEDFUSION SYRINGE INFUSION

Smiths medical is conducting a correction of medfusion¿ syringe infusion pumps, models 3010 and 3010a, with obsolete software versions 2.0.2, 2.0.3, and 2.0.4. smiths medical has found that pumps with obsolete software may continue to run past the set volume limit. this can result in an over-delivery if the syringe is over-filled. smiths ...

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Recall of Device Recall Medfusion 4000 Syringe Infusion

Smiths medical is conducting a recall involving all medfusion¿ 4000 syringe infusion pumps. smiths medical has identified an issue with electrical shorting at the ac power receptacle. shorting can occur when saline solution or other conductive fluids (e.G., potassium chloride) enter the ac power receptacle. when this happens, sparking and/ or flames, accompanied by smoke, may

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Rappel de Device Recall Medfusion Syringe Pump

Rappel de Device Recall Medfusion Syringe Pump Selon U.S ... Class 2 Numéro de l'événement Z-1134-2018 Date de mise en oeuvre de l'événement 2017-11-13 Date de publication de l'événement ... Certain medfusion syringe pump models, series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. the inability ...

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Medfusion Syringe Pump Recall Due to Medication Error

2020-8-25  Smith Medical sent an Urgent Medical Device Recall notice on June 26, instructing customers to verify the firmware version of the Medfusion® 3500 and

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Device Recall Medfusion Syringe Pump, 3500 Series 의 리콜

Device Recall Medfusion Syringe Pump, 3500 Series 의 리콜 U.S. Food and Drug Administration에 따르면, 해당 리콜 는 ... Class 2 사례 연번 Z-0314-2018 사례 시작날짜 2017-08-22 사례 상황 Open, Classified 사례 국가 United States 사례 출처 ...

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FDA Class I Recall: Smiths Medical Medfusion 3500 and

2020-8-26  FDA Class I Recall: Smiths Medical Medfusion 3500 and 4000 Syringe Pumps. ... Manufacturing Dates: November 1, 2013 to June 22, 2020 Devices Recalled in the U.S.: 46,395. The Smiths Medical Medfusion Syringe Pump delivers blood, blood products, prescribed drugs, and other fluids into a patient's body in a controlled manner. ...

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