9 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801; 4x4 digit format 2170-3000A 2170-3001A 2170-3002A 2170-3003A
FDA Enforcement
Class I
·Ongoing·Philips North America·February 14, 2024
BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161
FDA Enforcement
Class I
·Ongoing·Philips North America·February 14, 2024
BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 453560829261;
FDA Enforcement
Class I
·Ongoing·Philips North America·February 14, 2024
HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
FDA Enforcement
Class I
·Terminated·Philips North America, LLC·April 5, 2017
MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
FDA Enforcement
Class I
·Terminated·Philips North America, LLC·February 14, 2018
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·December 20, 2023
SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 989603050642.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·July 3, 2024
SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·July 3, 2024
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·July 3, 2024