Ingenia 3.0T CX-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: 781271
Check against the official notice below — it lists the full affected range.
Philips North America LLC is recalling the Ingenia 3.0T CX-a Magnetic Resonance imaging system, a diagnostic device used to produce cross-sectional and spectroscopic images. The recall affects 266 units distributed worldwide, including throughout the United States and numerous other countries. The problem occurs when the device is used in manual mode: the tabletop may fail to completely move in or out of the bore, potentially delaying patient evacuation from the machine and consequently delaying medical treatment.
The recall involves multiple serial numbers across various model designations (including models 78121, 78150, 78157, 78096, 78208, 78094, 78012, 78074, and many others). The specific serial numbers and unique device identifiers for affected units are listed in the recall documentation. The source document does not specify a remedy or corrective action for affected consumers or facilities.
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: 266 units Lot/code info: Serial Number Unique Device Identifier (UDI#) Model: 781271 78121 (01)00884838068452(21)78121 78150 (01)00884838068452(21)78150 78157 (01)00884838068452(21)78157 78096 N/A 78208 (01)00884838068452(21)78208 78094 N/A 78012 N/A 78074 N/A 78154 (01)00884838068452(21)78154 78161 N/A 78172 (01)00884838068452(21)78172 78170 (01)00884838068452(21)78170 78182 (01)00884838068452(21)78182 78183 (01)00884838068452(21)78183 78205 (01)00884838068452(21)78205 78196 (01)00884838068452(21)78196 78171 (01)00884838068452(21)78171 78213 (01)00884838068452(21)78213 78221 (01)00884838068452(21)78221 78210 (01)00884838068452(21)78210 78212 (01)00884838068452(21)78212 78233 (01)00884838068452(21)78233 78190 (01)00884838068452(21)78190 78198 (01)00884838068452(21)78198 78216 (01)00884838068452(21)78216 78225 (01)00884838068452(21)78225 78238 N/A 78242 (01)00884838068452(21)78242 78173 (01)00884838068452(21)78173 78251 (01)00884838068452(21)78251 78250 (01)00884838068452(21)78250 78241 (01)00884838068452(21)78241 78235 (01)00884838068452(21)78235 78262 (01)00884838068452(21)78262 78253 (01)00884838068452(21)78253 78244 (01)00884838068452(21)78244 78252 (01)00884838068452(21)78252 78256 (01)00884838068452(21)78256 78263 (01)00884838068452(21)78263 78257 N/A 78266 (01)00884838068452(21)78266 78267 (01)00884838068452(21)78267 78269 (01)00884838068452(21)78269 78265 (01)00884838068452(21)78265 78270 (01)00884838068452(21)78270 78284 (01)00884838068452(21)78284 78281 (01)00884838068452(21)78281 78289 (01)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.