Philips Achieva 1.5T Conversion recall — FDA Z-0946-2024
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to…
Complete FDA and NHTSA recall records dated in February 2024.
These records include useful source details for the selected month.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to…
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation…
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation…
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation…
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation…
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to…
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to…
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to…
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and…
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation…
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation…
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation…
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation…
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to…
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.