11 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Brilliance 64 Computed Tomography X-Ray System, 510(k) #K033326, Model Number: 728231, Serial Numbers: 9745, 90169, and 95414. The recalled device systems are equipped with Version 3.5 Beta 1 software.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 22, 2011
Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, and 300005. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·August 29, 2011
Brilliance Big Bore CT (Computed Tomography) System, 510 (k) #K033357, Model #728243, Serial Numbers: 7006, 7154, and 7349. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·August 29, 2011
Brilliance 64 CT (Computed Tomography) System, 510 (k) #K033326, Model #728231, Serial Numbers: 4003, 9875, and 90135. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·August 29, 2011
Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020 and 300021. Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·November 11, 2011
Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003, 300030, 95130, and 95157. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 6, 2011
Brilliance Big Bore Computed Tomography X-Ray System, 510(k) #K033357, Model Number: 728243, Serial Numbers: 7298, and 7060. The recalled device systems are equipped with Version 3.5 Beta 1 software. The Brilliance Big Bore and Brilliance 64 are Computed Tomography X-Ray Systems intended thio product cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 22, 2011
Ingenuity CT computed Tomography System, Model #728326, 510(k) #K 033326, Serial Numbers: 300010 and 300018. The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 6, 2011
Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, 300005, and 300010. Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-asectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·December 8, 2011
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013