Ingenia Ambition S-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: 781359
Check against the official notice below — it lists the full affected range.
Philips North America is recalling 99 units of the Ingenia Ambition S-a Magnetic Resonance (MRI) system worldwide due to a defect affecting the tabletop in manual mode. When using manual mode, the tabletop may not completely move in or out of the MRI bore, which could delay a patient's evacuation from the machine and potentially delay medical treatment.
The recall affects specific serial numbers of the device distributed across numerous countries including the United States. The source record does not specify what actions affected consumers or healthcare facilities should take in response to this recall.
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: 99 units Lot/code info: Serial Number Unique Device Identifier (UDI#) 48026 (01)00884838090057(21)48026 48016 (01)00884838090057(21)48016 48053 (01)00884838090057(21)48053 48003 (01)00884838090057(21)48003 48136 (01)00884838090057(21)48136 48144 (01)00884838090057(21)48144 48020 (01)00884838090057(21)48020 48155 (01)00884838090057(21)48155 48191 (01)00884838090057(21)48191 48216 (01)00884838090057(21)48216 48124 (01)00884838090057(21)48124 48030 (01)00884838090057(21)48030 48011 (01)00884838090057(21)48011 48183 (01)00884838090057(21)48183 48186 (01)00884838090057(21)48186 48187 (01)00884838090057(21)48187 48234 (01)00884838090057(21)48234 48051 (01)00884838090057(21)48051 48000 (01)00884838090057(21)48000 48004 (01)00884838090057(21)48004 48009 (01)00884838090057(21)48009 48005 (01)00884838090057(21)48005 48019 (01)00884838090057(21)48019 48032 (01)00884838090057(21)48032 48132 (01)00884838090057(21)48132 48224 (01)00884838090057(21)48224 48223 (01)00884838090057(21)48223 48207 (01)00884838090057(21)48207 48015 (01)00884838090057(21)48015 48028 N/A 48154 N/A 48160 N/A 48134 N/A 48049 N/A 48031 N/A 48050 N/A 48131 N/A 48040 (01)00884838090057(21)48040 48039 (01)00884838090057(21)48039 48152 (01)00884838090057(21)48152 48173 (01)00884838090057(21)48173 48122 (01)00884838090057(21)48122 48022 (01)00884838090057(21)48022 48012 (01)00884838090057(21)48012 48014 (01)00884838090057(21)48014 48037 (01)00884838090057(21)48037 48036 (01)00884838090057(21)48036 48158 (01)00884838090057(21)48158 48127 (01)0088
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.