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Class 2 Device Recall Philips |
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| Date Initiated by Firm |
August 11, 2021 |
| Create Date |
September 03, 2021 |
| Recall Status1 |
Completed |
| Recall Number |
Z-2421-2021 |
| Recall Event ID |
88491 |
| 510(K)Number |
K162931
|
| Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
| 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 |
| Code Information |
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
|
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 |
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.
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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 and Original Applicant = PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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