SmartPath to dStream for XR and 3.0T-a Magnetic recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…

Recalling firm

Philips North America Llc

Quantity

198 units

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, 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.

Recall date

September 15, 2021

Classification

Class II

Status

Completed

Agency

FDA (device)