—#188783

Product

Ingenia 1.5T Evolution-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 Model: 781315

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K162931
Affected lot / code info: Model: 78135 Serial Number Unique Device Identifier (UDI#) 61019 (01)00884838099715 61028 (01)00884838099715 61001 (01)00884838099715 61004 (01)00884838099715 61023 (01)00884838099715 61008 (01)00884838099715 61026 (01)00884838099715 61034 (01)00884838099715 61046 (01)00884838099715 61025 (01)00884838099715 61035 (01)00884838099715 61042 (01)00884838099715 61040 (01)00884838099715 61041 (01)00884838099715(21)61041 61007 (01)00884838099715 61014 (01)00884838099715 61018 (01)00884838099715 61000 N/A 61003 (01)00884838099715 61002 N/A 61006 N/A 61009 N/A 61013 N/A 61017 (01)00884838099715(21)61017 61032 (01)00884838099715(21)61032 61015 N/A 61005 (01)00884838099715 61020 (01)00884838099715 61043 (01)00884838099715 61029 (01)00884838099715 61030 (01)00884838099715 61033 (01)00884838099715(21)61033 61052 (01)00884838099715(21)61052 61064 (01)00884838099715(21)61064 61027 (01)00884838099715 61016 (01)00884838099715 61022 (01)00884838099715 61044 (01)00884838099715 61050 (01)00884838099715 61047 (01)00884838099715(21)61047 61053 (01)00884838099715(21)61053 61049 (01)00884838099715(21)61049

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

Philips notified U.S. customers an Urgent Medical Device Correction letter on 8/11/21. Letter states reason for recall, health risk and action to take: Philips advises that customers continue to utilize the primary motorized function for the MR system since the identified issue with the HDU does not occur in the motorized mode. If you utilize the manual function and it is not functioning properly, then you must perform table movement using the motorized function. A Philips Field Service Engineer (FSE) will perform a HDU during the next scheduled preventive maintenance visit. If the issue is detected in the HDU, the Philips FSE will replace the necessary mechanical component(s) to resolve the issue. If you need additional information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377) and reference FCO78100527.

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: 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, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.

Timeline

Recall initiated: 2021-08-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188783. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.