| | Class 2 Device Recall Philips |  |
| Date Initiated by Firm | August 11, 2021 |
|---|
| Create Date | September 03, 2021 |
|---|
| Recall Status1 |
Completed |
| Recall Number | Z-2415-2021 |
|---|
| Recall Event ID |
88491 |
| 510(K)Number | K162931 |
|---|
| Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
| Product | SmartPath to dStream for 1.5T-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: 781260 |
|---|
| Code Information |
Serial Number Unique Device Identifier (UDI#)
8750 N/A
32245 N/A
9013 N/A
8554 N/A
20211 N/A
18801 N/A
8178 N/A
10164 N/A
8752 N/A
10139 N/A
11076 N/A
8156 N/A
8646 N/A
22116 N/A
21175 N/A
8118 N/A
32443 N/A
32444 N/A
32445 N/A
18561 N/A
18761 N/A
30037 N/A
30146 N/A
21748 N/A
20003 N/A
21384 N/A
20116 N/A
20115 N/A
33220 N/A
18746 (01)00884838095076
8074 (01)00884838095076
18853 (01)00884838095076
21349 (01)00884838095076
18986 (01)00884838095076
18943 (01)00884838095076
18583 (01)00884838095076
22144 (01)00884838095076
22266 (01)00884838095076(21)22266
33045 (01)00884838095076(21)33045
32262 (01)00884838095076(21)32262
11100 (01)00884838095076(21)11100
5572 N/A
10236 N/A
12030 N/A
10183 N/A
72077 N/A
8985 N/A
21466 N/A
8240 N/A
32643 N/A
12084 N/A
8260 N/A
8942 N/A
21912 N/A
32180 N/A
21736 N/A
32059 (01)00884838095076
8917 N/A
10087 N/A
8713 N/A
10130 N/A
32621 N/A
18673 N/A
18701 N/A
30067 N/A
21775 (01)00884838095076
21679 N/A
32086 N/A
22220 N/A
8001 N/A
20070 N/A
10717 N/A
39103 N/A
5523 N/A
10511 N/A
10170 N/A
8642 N/A
21033 N/A
11030 N/A
10061 N/A
11031 N/A
8318 N/A
10174 N/A
18665 N/A
8611 N/A
8084 N/A
10191 N/A
8387 N/A
21932 N/A
8025 N/A
18644 N/A
5463 N/A
21142 N/A
8559 N/A
20057 N/A
11102 N/A
18631 N/A
8804 N/A
18565 N/A
5447 N/A
21015 N/A
10075 N/A
11062 N/A
30045 N/A
32176 N/A
8407 N/A
8512 N/A
8021 N/A
32752 N/A
21676 N/A
11001 N/A
18697 N/A
32710 N/A
32438 N/A
21171 N/A
39031 N/A
10033 N/A
5539 N/A
32636 N/A
21392 N/A
8129 N/A
8397 N/A
11108 N/A
11000 N/A
8704 N/A
13082 N/A
10179 N/A
8263 N/A
10523 N/A
32092 N/A
32113 N/A
32341 N/A
32334 N/A
8110 N/A
18957 N/A
8487 N/A
18938 N/A
32454 N/A
12082 N/A
9020 (01)00884838095076
9024 (01)00884838095076
8736 (01)00884838095076
8885 (01)00884838095076
22194 (01)00884838095076
21018 (01)00884838095076
21814 (01)00884838095076
5484 (01)00884838095076
10117 (01)00884838095076
8476 (01)00884838095076
30097 (01)00884838095076
8315 (01)00884838095076
32163 (01)00884838095076
32099 (01)00884838095076
8401 (01)00884838095076
21082 (01)00884838095076
21453 (01)00884838095076
18013 (01)00884838095076
18906 (01)00884838095076
32164 (01)00884838095076
8321 (01)00884838095076
8486 (01)00884838095076
10008 (01)00884838095076
18894 (01)00884838095076
32322 (01)00884838095076
8175 (01)00884838095076
32340 (01)00884838095076
39018 (01)00884838095076
5425 (01)00884838095076(21)5425
8096 (01)00884838095076(21)8096
8010 N/A
8179 N/A
39003 N/A
21003 N/A
8923 N/A
8087 N/A
8601 N/A
8659 N/A
18690 N/A
8215 N/A
32449 N/A
32127 N/A
32467 (01)00884838095076
8427 N/A
10528 (01)00884838095076
10900 N/A
21768 (01)00884838095076
8862 (01)00884838095076
21710 (01)00884838095076
8081 N/A
8485 N/A
8799 N/A
5490 N/A
5479 N/A
21294 N/A
8819 N/A
8967 N/A
8779 N/A
8746 N/A
8200 N/A
10716 N/A
12047 N/A
21477 N/A
8550 (01)00884838095076
21133 (01)00884838095076
21577 (01)00884838095076
32845 (01)00884838095076(21)32845
21050 N/A
21223 N/A
22154 N/A
21554 N/A
32754 N/A
32049 N/A
22070 N/A
72054 N/A
10079 N/A
20198 N/A
8895 N/A
21880 N/A
8884 N/A
21084 N/A
20151 N/A
20152 N/A
21804 N/A
8492 (01)00884838095076
32807 (01)00884838095076
5505 N/A
5499 N/A
8657 (01)00884838095076
32680 (01)00884838095076
32283 (01)00884838095076
10029 N/A
8054 N/A
8350 N/A
21087 N/A
21737 N/A
18940 N/A
32140 N/A
32361 N/A
21184 N/A
33126 N/A
21942 N/A
11072 N/A
21680 N/A
21691 N/A
33051 N/A
22103 N/A
32822 N/A
21694 N/A
18720 N/A
72081 N/A
21141 N/A
33023 (01)00884838095076
21247 (01)00884838095076
18575 (01)00884838095076
0 N/A
30132 (01)00884838095076(21)30132
18718 N/A
32285 (01)00884838095076(21)32285
21363 N/A
13011 N/A
20132 N/A
21032 N/A
22182 N/A
13052 N/A
9022 N/A
8119 N/A
18655 N/A
20111 N/A
32506 N/A
5466 N/A
21343 N/A
22299 N/A
32450 N/A
8786 N/A
8311 N/A
8395 N/A
9004 N/A
5546 N/A
5537 N/A
8712 N/A
8667 N/A
18101 N/A
10044 N/A
8478 N/A
10457 N/A
18511 N/A
10220 N/A
10554 N/A
0 N/A
11046 N/A
32264 N/A
32410 N/A
32492 N/A
18970 N/A
39037 N/A
8840 N/A
10185 N/A
13001 N/A
8365 N/A
72243 N/A
18509 N/A
33100 N/A
8641 N/A
18597 N/A
21623 N/A
18069 N/A
12036 N/A
8251 N/A
18035 N/A
22055 N/A
21011 N/A
32849 N/A
22296 N/A
32990 N/A
21551 N/A
11017 N/A
20164 N/A
8431 N/A
10552 N/A
8330 N/A
20196 N/A
21362 (01)00884838095076
21892 (01)00884838095076
20413 (01)00884838095076
72239 (01)00884838095076
22044 (01)00884838095076
8045 (01)00884838095076
21890 (01)00884838095076
21809 (01)00884838095076(21)21809
32478 (01)00884838095076(21)32478
8591 N/A
13032 N/A
22227 N/A
8012 N/A
8724 N/A
8949 N/A
13073 N/A
20288 N/A
20263 N/A
21482 N/A
5511 N/A
10208 N/A
8481 N/A
8555 N/A
10498 N/A
11042 N/A
8857 N/A
22098 N/A
13062 N/A
21278 N/A
21129 N/A
9007 N/A
11047 N/A
13029 N/A
18038 N/A
12114 N/A
8896 N/A
11091 N/A
13047 N/A
8057 N/A
12055 N/A
20302 N/A
8309 N/A
21560 N/A
21156 N/A
10906 N/A
10513 N/A
21697 N/A
20033 N/A
13046 N/A
10719 N/A
21759 N/A
20319 N/A
8831 N/A
10913 N/A
18060 N/A
10151 N/A
8060 N/A
21062 N/A
20002 N/A
18929 N/A
8531 N/A
11005 N/A
18107 N/A
20195 N/A
20011 N/A
8843 N/A
20237 N/A
21969 N/A
20278 N/A
21355 N/A
8305 N/A
18704 N/A
21583 N/A
8913 N/A
21222 N/A
20209 N/A
20187 N/A
21780 N/A
8094 N/A
8561 N/A
22013 N/A
8711 N/A
21987 N/A
12120 N/A
10007 N/A
21209 N/A
21182 N/A
21403 N/A
21640 N/A
8887 N/A
18524 N/A
21213 N/A
21519 N/A
21579 N/A
21448 (01)00884838095076
22184 (01)00884838095076
18017 (01)00884838095076
18954 (01)00884838095076
22157 (01)00884838095076
8517 (01)00884838095076
22248 (01)00884838095076
21089 (01)00884838095076
22123 (01)00884838095076
21249 (01)00884838095076
32258 (01)00884838095076(21)32258
32236 (01)00884838095076(21)32236
39009 (01)00884838095076(21)39009
20035 (01)00884838095076(21)20035
22175 (01)00884838095076(21)22175
21326 (01)00884838095076(21)21326
32132 (01)00884838095076(21)32132
10458 N/A
10544 N/A
10915 N/A
21253 N/A
22031 (01)00884838095076(21)22031
18808 N/A
13069 N/A
33352 (01)00884838095076
8091 N/A
18800 N/A
21067 N/A
21481 N/A
18610 N/A
18948 (01)00884838095076
33062 (01)00884838095076
22237 (01)00884838095076
8686 N/A
21023 N/A
8378 N/A
5563 N/A
18663 N/A
21019 N/A
8639 N/A
32742 N/A
20322 N/A
18699 (01)00884838095076
22347 (01)00884838095076
32119 (01)00884838095076(21)32119
8608 N/A
8783 N/A
21960 N/A
8086 N/A
21458 N/A
22189 N/A
21591 N/A
8292 N/A
10543 N/A
32573 (01)00884838095076
8566 N/A
32145 (01)00884838095076
10086 N/A
8983 N/A
18985 (01)00884838095076
21621 (01)00884838095076
22342 N/A
32391 N/A
8723 N/A
22301 N/A
10530 (01)00884838095076
10161 (01)00884838095076(21)10161
21498 N/A
8168 N/A
8451 N/A
18512 N/A
21929 N/A
22285 N/A
8616 N/A
8706 N/A
8687 N/A
32311 N/A
32513 N/A
20112 N/A
32094 N/A
12134 N/A
21888 N/A
32184 N/A
21438 N/A
22060 N/A
8092 N/A
32406 N/A
13018 N/A
8948 N/A
22127 N/A
32221 N/A
32218 N/A
8851 N/A
11085 N/A
12072 N/A
32147 N/A
32374 N/A
32405 N/A
22102 N/A
32296 N/A
22137 (01)00884838095076
22100 (01)00884838095076
8190 N/A
32142 N/A
10570 N/A
11018 N/A
12115 N/A
8392 N/A
22107 N/A
39024 N/A
21290 N/A
10077 N/A
10703 N/A
39005 N/A
8715 N/A
20071 N/A
8996 N/A
21540 N/A
18528 N/A
20226 N/A
8971 N/A
8578 N/A
12033 N/A
32174 N/A
8630 N/A
10196 N/A
21664 N/A
8560 N/A
18559 N/A
32131 N/A
18726 N/A
21108 N/A
8772 N/A
8835 N/A
18558 N/A
10154 N/A
21788 (01)00884838095076
8100 (01)00884838095076
5475 (01)00884838095076
9001 (01)00884838095076
12034 (01)00884838095076
10036 (01)00884838095076
10482 (01)00884838095076
8906 (01)00884838095076
8760 (01)00884838095076
8975 (01)00884838095076(21)8975
8354 N/A
9006 N/A
32200 N/A
8694 (01)00884838095076
|
Recalling Firm/
Manufacturer |
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
|
Manufacturer 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 |
|---|
FDA Determined
Cause 2 | Device Design |
|---|
| Action | 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. |
|---|
| Quantity in Commerce | 566 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.
|
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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| 510(K) Database | 510(K)s with Product Code = LNH
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