All recalls8,501 total
Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
Product does not have FDA clearance.
The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
Salmonella spp. identified in finished product testing
Undeclared allergen: Soy Lecithin
Package integrity compromised.
Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.
Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.
Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and CRT Ds. Medtronic recommends physicians use increased caution when using the Sphere-9 catheter for RF ablation therapy in patients implanted with a Biotronik ICD/CRT-D system, and to ensure external defibrillation systems are readily available.
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
Undeclared Allergen - Wheat and Soy (from Soy Lecithin). The ingredient statement and allergen information do not include wheat or soy.
An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss of the actuator's ability to hold the load, leading to rapid and uncontrolled downward movement of the lifting arm.
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
Undeclared Soy.
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
There is a possibility of reagent leakage from the specimen container.
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.