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There have been 51 complaints, one death related to this recall and one reported injury, the FDA said. The company has asked customers to not use the device for high-risk medications, and only use ...
The medical device maker started the recall process on Dec. 27 last year and has recalled 66,390 devices in the United States. The recalled devices were distributed for two years until Oct. 10, 2023.
(Reuters) -The U.S. FDA said on Thursday it has classified a recall of Philips' medical imaging machines as most serious due to the risk of a detector in some devices unexpectedly falling on ...
The recall applies to Life2000 ventilators with the product code MS01-0118 that have the attached battery charger dongle, and were distributed in the U.S. from Aug. 21, 2023 to April 2, 2024 ...
The devices are used in patients undergoing cardiac and non-cardiac surgery, and to treat those who have had heart failure or have acute coronary syndrome, a group of diseases in which blood flow ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
On Wednesday, ICU Medical Inc’s (NASDAQ:ICUI) subsidiary, Smiths Medical, initiated a recall of certain Bivona neonatal/pediatric and adult tracheostomy tubes. The FDA classified the recall as ...
The FDA said the recall of the device BioZorb Marker, initiated by Hologic in March, was not a product removal, but a correction. The agency also urged patients to report any side effects they ...