Ingenia 3.0T-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: 781342 781377
Check against the official notice below — it lists the full affected range.
Philips North America is recalling Ingenia 3.0T-a Magnetic Resonance medical imaging systems distributed worldwide, including across the United States and numerous international locations. A total of 1,386 units are affected across various model numbers. The recalled systems can experience a malfunction in manual mode where the patient tabletop may not completely move in or out of the imaging bore, potentially delaying patient evacuation and treatment.
The source does not specify any remedy, replacement, repair, or other 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: 964 units, 422 units Lot/code info: Serial Number Unique Device Identifier (UDI#) Model: 781342 71352 N/A 71426 N/A 71977 (01)00884838055339(21)71977 85020 (01)00884838055339(21)85020 85106 (01)00884838055339(21)85106 71011 N/A 71152 N/A 71526 N/A 71433 (01)00884838055339(21)71433 71710 (01)00884838055339(21)71710 71817 (01)00884838055339(21)71817 71812 (01)00884838055339(21)71812 71403 (01)00884838055339(21)71403 71311 N/A 71345 N/A 71392 N/A 71395 N/A 71628 N/A 71723 (01)00884838055339(21)71723 85393 (01)00884838055339(21)85393 71042 N/A 71101 N/A 71168 N/A 71179 N/A 71178 N/A 71214 N/A 71252 N/A 71313 N/A 71342 N/A 71328 N/A 71309 N/A 71419 N/A 71453 N/A 71555 N/A 71557 N/A 71550 N/A 71551 N/A 71693 (01)00884838055339(21)71693 71674 (01)00884838055339(21)71674 71733 (01)00884838055339(21)71733 71859 (01)00884838055339(21)71859 71949 (01)00884838055339(21)71949 71993 (01)00884838055339(21)71993 71994 (01)00884838055339(21)71994 85045 (01)00884838055339(21)85045 85036 (01)00884838055339(21)85036 85155 (01)00884838055339(21)85155 85115 (01)00884838055339(21)85115 71602 (01)00884838055339(21)71602 71216 N/A 71651 N/A 71950 (01)00884838055339(21)71950 85208 (01)00884838055339(21)85208 71163 N/A 71408 N/A 71499 N/A 71493 N/A 71541 N/A 71580 N/A 71668 (01)00884838055339(21)71668 71729 (01)00884838055339(21)71729 71771 (01)00884838055339(21)71771 71726 (01)00884838055339(21)71726 71260 N/A 71324 N/A 71276 N/A 71800 (01)00884838055339(21)71800 71068 N/A 71081 N/A 71300 N/A 71481 N/A 71482 N/A 71006 N/A 71018 N/A 7104
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.