Ingenia 1.5T- 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: 781341 781396
Check against the official notice below — it lists the full affected range.
Philips North America is recalling its Ingenia 1.5T magnetic resonance imaging (MRI) systems due to a hazard affecting the patient tabletop in manual mode. When using manual mode, the tabletop may fail to move completely in or out of the scanner bore, which could delay a patient's evacuation from the machine and potentially delay medical treatment. The recall affects approximately 2,005 units (1,517 and 488 units) distributed worldwide, including throughout the United States and numerous countries.
The affected systems are Model 781341 with multiple serial numbers listed in the recall documentation. The recall document does not specify a remedy or corrective action that affected consumers should take.
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: 1517 units, 488 units Lot/code info: Model: 781341 Serial Number Unique Device Identifier (UDI#) 70085 N/A 70160 N/A 70246 N/A 70349 N/A 70348 N/A 70407 N/A 70723 N/A 70873 N/A 70917 N/A 87101 (01)00884838055322(21)87101 70040 N/A 70229 N/A 70607 N/A 70763 N/A 84126 (01)00884838055322(21)84126 84030 (01)00884838055322(21)84030 84108 (01)00884838055322(21)84108 84234 (01)00884838055322(21)84234 84257 N/A 84596 (01)00884838055322(21)84596 87005 (01)00884838055322(21)87005 87146 (01)00884838055322(21)87146 70279 N/A 70367 N/A 70374 N/A 70375 N/A 70461 N/A 70471 N/A 70742 N/A 70764 N/A 70064 N/A 70113 N/A 70604 N/A 70603 N/A 70605 N/A 70725 N/A 70704 N/A 70768 N/A 70794 N/A 70766 N/A 70812 N/A 70767 N/A 84539 (01)00884838055322(21)84539 70780 N/A 84566 (01)00884838055322(21)84566 84621 (01)00884838055322(21)84621 84667 (01)00884838055322(21)84667 84629 (01)00884838055322(21)84629 84962 (01)00884838055322(21)84962 87214 (01)00884838055322(21)87214 87215 (01)00884838055322(21)87215 70071 N/A 70284 N/A 70311 N/A 70916 N/A 84098 (01)00884838055322(21)84098 84343 (01)00884838055322(21)84343 84249 (01)00884838055322(21)84249 84891 (01)00884838055322(21)84891 84765 (01)00884838055322(21)84765 70110 N/A 70111 N/A 70177 N/A 70161 N/A 70204 N/A 70205 N/A 70244 N/A 70269 N/A 70088 N/A 70446 N/A 70448 N/A 70470 N/A 70665 N/A 70678 N/A 70459 N/A 70755 N/A 70666 N/A 70664 N/A 70663 N/A 70667 N/A 70668 N/A 70662 N/A 70864 N/A 70845 N/A 70943 N/A 70942 N/A 70866 N/A 70868 N/A 70867 N/A 70969 N/A 70691 N/A 70612 (01)00884838055322(2
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.