Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781358
Check against the official notice below — it lists the full affected range.
Philips North America LLC is recalling 228 units of the Ingenia Elition X-a Magnetic Resonance Medical Electrical System, which is used to produce diagnostic imaging. The recall addresses a defect in manual mode operation where the patient tabletop may not completely move in or out of the scanner bore, potentially delaying patient evacuation and treatment.
The affected devices have been distributed worldwide, including throughout the United States and numerous other countries. The specific serial numbers of the recalled units are listed in the recall notice. The recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Reason for recall: When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment Distribution: Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Guiana, Georgia, Ge Quantity: 228 units Lot/code info: Serial Number Unique Device Identifier (UDI#) Model: 781358 45153 (01)00884838088115(21)45153 45062 (01)00884838088115(21)45062 45107 (01)00884838088115(21)45107 45144 (01)00884838088115(21)45144 45145 (01)00884838088115(21)45145 45142 (01)00884838088115(21)45142 45215 (01)00884838088115(21)45215 45216 (01)00884838088115(21)45216 45284 (01)00884838088115(21)45284 45079 (01)00884838088115(21)45079 45121 (01)00884838088115(21)45121 45007 (01)00884838088115(21)45007 45154 (01)00884838088115(21)45154 45127 (01)00884838088115(21)45127 45052 (01)00884838088115(21)45052 45193 (01)00884838088115(21)45193 45253 (01)00884838088115(21)45253 45042 (01)00884838088115(21)45042 45045 (01)00884838088115(21)45045 45136 (01)00884838088115(21)45136 45119 (01)00884838088115(21)45119 45197 (01)00884838088115(21)45197 45195 (01)00884838088115(21)45195 45097 (01)00884838088115(21)45097 45106 N/A 45131 N/A 45259 (01)00884838088115(21)45259 45300 (01)00884838088115(21)45300 45313 (01)00884838088115(21)45313 45298 (01)00884838088115(21)45298 45265 (01)00884838088115(21)45265 45000 (01)00884838088115 45039 (01)00884838088115(21)45039 45047 (01)00884838088115(21)45047 45080 (01)00884838088115(21)45080 45056 (01)00884838088115(21)45056 45137 (01)00884838088115(21)45137 45129 (01)00884838088115(21)45129 45109 (01)00884838088115(21)45109 45171 (01)00884838088115(21)45171 45205 (01)00884838088115(21)45205 45210 (01)00884838088115(21)45210 45188 (01)00884838088115(21)45188 45297 (01)00884838088115(21)45297 4
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.