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URGENT - Field Safety Notice 2016-06-01 | EVU-155312_2 | Maquet Critical Care AB SE-171 54 Solna, Sweden www.maquet.com MM-0191 | 09 1 of 3 Please forward this information to all relevant users, biomedical staff and risk
Chat OnlineURGENT-Field Safety Notice FC072200260 C-arcbrake of the Allura Xper R8.2 FD2O C fails to engage. Dear Customer, At our manufacturing site we have noticed an issue of a Philips Allura System that, if it were to re-occur,could potentially pose a risk for the patient and or user. This Field Safety Notice notification is intended to inform you about:
Chat OnlineFrance Tél. : +33 (0)3 20 14 41 19 +33 (0)6 25 22 40 00 Fax : +33 (0)3 20 14 40 13 Mail: [email protected] www. cousin-biotech.com URGENT FIELD SAFETY NOTICE Cousin Biotech FSN # 2017-01-04 Date : 04 January 2017 Concerned product references : GCBCYSTOSU (BIOMESH® SOFT PROLAPS) GCBINSOFTU (SOFT LIFT®) ...
Chat OnlineThe recall notification (U.S. and Canada) / field safety notice (International Markets) informs customers and users of potential impacts on patient health and clinical use related to this issue. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure ...
Chat OnlineDec 02, 2015· Publications. Search for European Commission planning and strategy documents, factsheets, studies, tender opportunities and other official notices. Find EU laws, statistics and public opinion documents.
Chat OnlineJun 15, 2021· Patient safety is at the heart of everything we do at Philips.” ... *This is a recall notification for the US only, and a field safety notice for the rest of the world
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Chat OnlineUrgent! Field Safety Notice (FSN) Transmission of the Field Safety Notice: CMSII (CMSI) 2728879 GETinGE ~C Vemon Gültig ab (Version) (vdd tom) V 01 Lut slgnature Page 3 of3 • Thls notice needs to be passee! on to all those who need to be aware wlthin your organlzatlon or to any organizatlon where the potentially affected devices have been
Chat OnlineUrgent Field Safety Notice: TCM5 FLEX/BASIC used with ECG monitor Dear Customer Radiometer has recently received reports of occurrences of the TCM5 causing interferences on ECG and EEG monitors. Radiometer acknowledges that there is a possibility that TCM5 FLEX/BASIC can cause interferences to ECG or EEG measurements, however, only when …
Chat OnlineDec 01, 2021· An urgent recall has been issued for a popular brand of shampoo sold at Priceline and Chemist Warehouse over concerns it contains bacteria that could cause ''serious illness''.
Chat OnlineOct 21, 2020· Up to5%cash back· Field Safety Notice with the instructions for use of the Device. Philips has become aware of a number of complaints related to possible inaccurate measurements by the Device. Philips has identified that the risk of delaying treatment can have serious consequences for newborns (0-3 months), small children (4-36 months) and Patients of
Chat OnlineThis urgent field safety notice has been notified to the co-ordinating national competent authority in Germany, the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). FSN 1610_04 - FSN Page 4 of 4 . We would like to thank you for your understanding and support in implementing this corrective action.
Chat OnlineRegulatory Updates Extension of Minimum Slot Usage Requirements. The FAA issued an extension of limited waiver (PDF) through March 26, 2022 of the minimum-slot-usage requirement at John F. Kennedy International Airport (JFK), LaGuardia Airport (LGA), and Ronald Reagan Washington National Airport (DCA).Additionally, the FAA also extended through March 26, …
Chat OnlineFor industry information about COVID-19, visit our COVID-19 Drugs and vaccines section. Guidance documents have been prepared to assist in the interpretation of policies and governing statutes and regulations. They are intended to assist in preparing drug submissions when seeking an approval to sell a pharmaceutical drug product in Canada. A. B.
Chat OnlineUrgent Field Safety Notice (FSN) GentleCath Air for Women 1. Information on Affected Devices* 1. 1. Device Type(s)* This intermittent catheter is indicated for self-catheterisation and routine transient ... were received from France market: 3 different sizes of CH in the box of CH10 size products. Mixed products found in 2 boxes.
Chat OnlineDec 07, 2017· The warning letter for the safety violation is written by the manager of the company when he finds someone violating the safety regulations of the company. This letter is started with the details of those safety regulations which have been violated and then it proceeds to the description of all those actions that can be taken if the employee ...
Chat OnlineUrgent Field Safety Notice IMC 17-07.B.OUS – July, 2018 The IMMULITE 2000/ IMMULITE 2000 XPi PSA assay Working Range is 0.04–150 ng/mL. The final revised hook value for IMMULITE 2000/IMMULITE 2000 XPi is 4,277 (versus 6,200 ng/mL communicated to customers previously), as testing demonstrated that samples with a total PSA
Chat OnlineFrance • +33153010911 +3226791079 All other countries _____ NO, I do not have any Volcano s5i/CORE/CORE Mobile systems with software v3.5. _____ YES, I have Volcano s5i/CORE/CORE Mobile systems with software v3.5 and acknowledge the receipt of this notice. Completed By: Name Signature Date Questions? Please call +32 2 713 18 20.
Chat OnlineInternational Medical Devices Database. By the International Consortium of Investigative Journalists. facebook twitter linkedin email. Embed. Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. Search.
Chat OnlineUrgent Field Safety Notice IMC 17-07.B.OUS – July, 2018 The IMMULITE 2000/ IMMULITE 2000 XPi PSA assay Working Range is 0.04–150 ng/mL. The final revised hook value for IMMULITE 2000/IMMULITE 2000 XPi is 4,277 (versus 6,200 ng/mL communicated to customers previously), as testing demonstrated that samples with a total PSA
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