—#188860

Product

SmartPath to dStream for XR and 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: 781270

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K162931
Affected lot / code info: Serial Number Unique Device Identifier (UDI#) Model: 781270 17536 N/A 24013 N/A 17508 N/A 17212 N/A 38184 (01)00884838095083 17546 N/A 38366 N/A 17290 N/A 34060 N/A 35056 N/A 23011 N/A 38076 N/A 38013 N/A 17369 N/A 17286 N/A 17172 N/A 24025 N/A 35031 N/A 17566 N/A 17490 N/A 17360 N/A 24007 N/A 38199 N/A 35042 N/A 38126 N/A 17302 N/A 17429 (01)00884838095083 24108 N/A 17473 N/A 38317 N/A 35043 N/A 35087 N/A 38040 N/A 17544 N/A 34152 N/A 17204 N/A 17339 N/A 38037 N/A 34032 N/A 23030 N/A 35044 N/A 17416 N/A 17440 N/A 38202 N/A 34145 N/A 38192 N/A 17436 N/A 38038 N/A 17398 N/A 17292 N/A 34211 (01)00884838095083 17264 (01)00884838095083 24055 (01)00884838095083 17415 (01)00884838095083 34142 (01)00884838095083 17283 N/A 38084 N/A 38198 N/A 17386 N/A 17006 N/A 17378 N/A 17533 N/A 38062 (01)00884838095083 35073 (01)00884838095083 34080 N/A 38116 N/A 17583 N/A 38214 N/A 38356 N/A 34111 N/A 35052 N/A 17590 N/A 38235 N/A 34037 N/A 38102 N/A 74011 N/A 38023 N/A 17406 (01)00884838095083 38063 N/A 17265 N/A 24036 N/A 35020 N/A 38135 N/A 17247 N/A 17517 (01)00884838095083(21)17517 34107 N/A 35060 N/A 17524 N/A 17514 N/A 24095 N/A 23026 N/A 24087 N/A 34236 (01)00884838095083 34249 (01)00884838095083 17231 N/A 17222 N/A 17308 N/A 17342 N/A 17388 N/A 17559 N/A 24143 N/A 38005 N/A 38014 N/A 38015 N/A 35048 N/A 38041 N/A 38081 N/A 38168 N/A 17242 N/A 38161 N/A 17245 N/A 38089 N/A 17589 N/A 24124 N/A 17499 N/A 17250 N/A 17468 N/A 24012 N/A 17299 N/A 17564 N/A 17565 N/A 24111 N/A 17493 N/A 17309 N/A 17357 (01)00884838095083 24110 (01)00884838095083 17464 (01)00884838095083 34221 (01)00884838095083 24006 (01)00884838095083 17556 (01)00884838095083 24134 (01)00884838095083 24023 (01)00884838095083 34090 (01)00884838095083 38032 (01)00884838095083 24109 (01)00884838095083 17399 (01)00884838095083(21)17399 34246 (01)00884838095083(21)34246 17594 N/A 24117 N/A 34096 N/A 38006 N/A 38417 N/A 38120 N/A 17495 N/A 38263 N/A 34292 N/A 34154 N/A 34233 N/A 17321 N/A 24090 N/A 17471 N/A 17428 N/A 17458 N/A 17194 N/A 38071 N/A 17246 N/A 38134 N/A 38131 N/A 38026 (01)00884838095083 17550 N/A 17610 N/A 17610 N/A 24145 (01)00884838095083 38217 (01)00884838095083 38225 (01)00884838095083 34250 N/A 17237 N/A 24075 N/A 24018 N/A 17326 N/A 17466 N/A 38138 (01)00884838095083 38111 N/A 17356 (01)00884838095083 38065 N/A 38300 N/A 38259 N/A 38045 N/A 23033 N/A 17239 N/A 34019 N/A 35032 N/A 34098 N/A 24076 N/A 34058 N/A 34223 N/A 17240 N/A 35019 N/A 38091 N/A 17375 N/A 17215 N/A 17459 N/A 24058 N/A 24066 N/A 17516 (01)00884838095083 17284 (01)00884838095083 17366 N/A 17352 N/A

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 #188860. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.